Devices › Laparoscope, general & plastic surgery
Device brand name · Laparoscope general & plastic surgery
Sm Plus Btt/Oval Balloon Dissector: medical device reports filed with FDA
194 reports name it, 2007–2017. Manufacturer given most often on reports: Covidien Formerly Ussc Puerto Rico. Product code GCJ.
- 194
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 94.3%
- classified as malfunction
- 90.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 194 reports that name the brand "Sm Plus Btt/Oval Balloon Dissector" (laparoscope general & plastic surgery), received between March 2007 and February 2017; the manufacturer given most often on reports is Covidien Formerly Ussc Puerto Rico. Spellings of one product vary from report to report.
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 (94.3%) and injury (4.6%); across all laparoscope, general & plastic surgery reports (product code GCJ) death is recorded in 0.3% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are inflation problem (41.8%), break (19.1%) and burst container or vessel (6.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, foreign body, removal of and tissue damage. 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 Sm Plus Btt/Oval Balloon Dissector was received in the five years to August 2026; the latest was received in February 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 84,093 reports carrying product code GCJ. 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 |
|---|---|---|---|
| Inflation problem | 81 | 41.8% | 4.3% |
| Breakthe device broke | 37 | 19.1% | 13.5% |
| Burst container or vessel | 13 | 6.7% | 0.8% |
| Air leak | 12 | 6.2% | 2.2% |
| Detachment of device component | 9 | 4.6% | 5.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 4.6% | 1% |
| Balloon rupture | 8 | 4.1% | 0.2% |
| Device, removal of (non-implant) | 8 | 4.1% | 0.8% |
| Replace | 6 | 3.1% | 12.3% |
| Crackthe device cracked | 5 | 2.6% | 1.5% |
| Gas/air leak | 5 | 2.6% | 1.7% |
| Leak/splashthe device leaked | 5 | 2.6% | 3.9% |
| Deflation problem | 4 | 2.1% | 0.1% |
| Material separation | 4 | 2.1% | 1.4% |
| Material integrity problema problem with the device material | 3 | 1.5% | 0.6% |
| Material rupture | 3 | 1.5% | 0.5% |
| Defective component | 2 | 1% | 0.3% |
| Defective devicethe device was defective | 2 | 1% | 0.3% |
| Difficult or delayed positioning | 2 | 1% | 0% |
| Insufficient device problem information | 2 | 1% | 0.6% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 16 | 8.2% |
| Foreign body, removal of | 9 | 4.6% |
| Tissue damage | 8 | 4.1% |
| No patient involvement | 6 | 3.1% |
| Blood loss | 3 | 1.5% |
| Injurya physical injury | 3 | 1.5% |
| Surgery, prolonged | 2 | 1% |
| Bleeding | 1 | 0.5% |
| Laceration(s) | 1 | 0.5% |
| Laparotomy | 1 | 0.5% |
| Peritoneal laceration(s) | 1 | 0.5% |
| Rupturethe device burst | 1 | 0.5% |
| Therapy/non-surgical treatment, additional | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sm Plus Btt/Oval Balloon Dissector | Product code GCJ | All MAUDE reports |
|---|---|---|---|
| Reports | 194 | 84,093 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 4.6% | 8.3% | 36.2% |
| Classified as malfunction | 94.3% | 90.1% | 62.3% |
| Filed by the manufacturer | 100% | 94.8% | 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 GCJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endoeye Flex Deflectable Videoscope | 8,062 | 2,245 | 0% |
| Auto Suture | 3,100 | 234 | 0.1% |
| Endopath Dilating Tip Trocar | 2,475 | 0 | 0.4% |
| VersaOne | 1,890 | 251 | 0.2% |
| Endoeye Flex 3d Deflectable Videoscope | 1,825 | 711 | 0% |
| Spacemaker | 1,379 | 146 | 0% |
| Versaport | 1,198 | 64 | 0.1% |
| Endopath Disposable Surgical Trocar | 1,153 | 0 | 0.4% |
| Pdb | 1,253 | 180 | 0% |
| Endopath Xcel Bladeless Trocar | 986 | 28 | 0.3% |
| Auto Suture Multifire Endo Gia 30-2 5 | 933 | 0 | 0% |
| Endopath Xcel Trocar | 844 | 0 | 0.9% |
| Lapro-Clip | 856 | 54 | 0.2% |
| Auto Suture Endo Clip 5mm | 795 | 0 | 0% |
| Endopath Xcel | 786 | 38 | 0.5% |
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 Sm Plus Btt/Oval Balloon Dissector reports
How many FDA reports name Sm Plus Btt/Oval Balloon Dissector?
194 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 (94.3%) and injury (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inflation problem (41.8%), break (19.1%), burst container or vessel (6.7%), air leak (6.2%) and detachment of device component (4.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sm Plus Btt/Oval Balloon Dissector 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.