Devices › Laparoscope, gynecologic (and accessories)
Device brand name · Laparoscope gynecologic
Gynecare Morcellex Tissue Morcellator: medical device reports filed with FDA
2,424 reports name it, 2007–2016. Manufacturer given most often on reports: Ethicon. Product code HET.
- 2,424
- device reports naming the brand
- 0% of all MAUDE reports · about 124 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 95.1%
- classified as malfunction
- 95.6% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
2,424 medical device reports received by FDA name the brand "Gynecare Morcellex Tissue Morcellator" (laparoscope gynecologic); the manufacturer given most often on reports is Ethicon; received from January 2007 to July 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (95.1%) and injury (4.7%); across all laparoscope, gynecologic (and accessories) reports (product code HET) death is recorded in 0.1% and malfunction in 95.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are other (for use when an appropriate device code cannot be identified) (97.4%), material perforation (0.5%) and tear, rip or hole in device packaging (0.5%). The patient problems coded most often are surgical procedure, additional, surgical procedure and internal organ perforation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Gynecare Morcellex Tissue Morcellator was received in the five years to August 2026; the latest was received in July 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 17,255 reports carrying product code HET. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 2,362 | 97.4% | 20.8% |
| Material perforation | 13 | 0.5% | 0.1% |
| Tear, rip or hole in device packaging | 12 | 0.5% | 0.1% |
| Failure to cut | 8 | 0.3% | 1.3% |
| Device inoperablethe device could not be used | 4 | 0.2% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 0.2% | 0.2% |
| Implant, removal of | 4 | 0.2% | 0% |
| Malfunction | 3 | 0.1% | 0% |
| Replace | 3 | 0.1% | 0.4% |
| Device issuea problem with the device | 2 | 0.1% | 0.1% |
| Tears, rips, holes in device, device material | 2 | 0.1% | 0.2% |
| Unsealed device packaging | 2 | 0.1% | 0% |
| Activation, positioning or separation problem | 1 | 0% | 0% |
| Breakthe device broke | 1 | 0% | 9.2% |
| Difficult or delayed activation | 1 | 0% | 0% |
| Difficult or delayed positioning | 1 | 0% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0% | 0.1% |
| Dull, blunt | 1 | 0% | 0.2% |
| Failure to advance | 1 | 0% | 0% |
| Failure to power up | 1 | 0% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure, additional | 82 | 3.4% |
| Surgical procedure | 24 | 1% |
| Internal organ perforation | 8 | 0.3% |
| Treatment with medication(s) | 8 | 0.3% |
| Bleeding | 5 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 0.2% |
| Perforation of vessels | 5 | 0.2% |
| Surgery, prolonged | 5 | 0.2% |
| Hospitalization required | 4 | 0.2% |
| Transfusion of blood products | 3 | 0.1% |
| Burn(s)a burn | 2 | 0.1% |
| Burn, incisional | 2 | 0.1% |
| Laceration(s) | 2 | 0.1% |
| Nonresorbable materials, unretrieved in body | 2 | 0.1% |
| Blood pressure, decreased | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gynecare Morcellex Tissue Morcellator | Product code HET | All MAUDE reports |
|---|---|---|---|
| Reports | 2,424 | 17,255 | 26,136,888 |
| Share of that pool | — | 14% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 4.7% | 3.7% | 36.2% |
| Classified as malfunction | 95.1% | 95.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 98.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code HET
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare X-Tract Morcellator | 1,062 | 0 | 0.6% |
| Cb030 5mmx35cm Epix Lapa Scissor 10/Bx | 281 | 0 | 0% |
| Gynecare Morcellex Unknown Product | 254 | 0 | 1.6% |
| Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable | 164 | 64 | 0% |
| Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable | 989 | 355 | 0% |
| Visera Elite Video System Center | 2,688 | 572 | 0% |
| Prestige Atra Grasper Dbl-Act 5mm | 255 | 0 | 0% |
| Karl Storz | 633 | 0 | 2.1% |
| Visera 4k Uhd Camera Control Unit | 1,860 | 425 | 0% |
| HD EndoEYE LAPARO-THORACO VIDEOSCOPE | 356 | 55 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
| da Vinci | 1,483 | 404 | 1.2% |
| Endoeye Flex 3d Deflectable Videoscope | 1,825 | 711 | 0% |
| Endopath Xcel | 786 | 38 | 0.5% |
| Essure | 74,072 | 435 | 0.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Gynecare Morcellex Tissue Morcellator reports
How many FDA reports name Gynecare Morcellex Tissue Morcellator?
2,424 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (95.1%) and injury (4.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (97.4%), material perforation (0.5%), tear, rip or hole in device packaging (0.5%), failure to cut (0.3%) and device inoperable (0.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gynecare Morcellex Tissue Morcellator was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.