Devices › Laparoscope, general & plastic surgery
Device brand name · Laparoscope general & plastic surgery
Spacemaker: medical device reports filed with FDA
1,379 reports name it, 2014–2026. Manufacturer given most often on reports: US Surgical Puerto Rico. Product code GCJ.
- 1,379
- device reports naming the brand
- 0% of all MAUDE reports · about 110 a year
- 146
- reports, 12 months to August 2026
- 137 in the 12 months before
- 97%
- 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 1,379 reports that name the brand "Spacemaker" (laparoscope general & plastic surgery), received between January 2014 and August 2026; the manufacturer given most often on reports is US Surgical Puerto Rico. Spellings of one product vary from report to report.
146 reports arrived in the 12 months to August 2026, close to the 137 of 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 (97%) and injury (3%); 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 break (42.7%), inflation problem (37%) and detachment of device or device component (13.8%). The patient problems coded most often are no patient involvement, hemorrhage/blood loss/bleeding and tissue breakdown. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Breakthe device broke | 589 | 42.7% | 13.5% |
| Inflation problem | 510 | 37% | 4.3% |
| Detachment of device or device componentpart of the device came off | 190 | 13.8% | 6% |
| Packaging problem | 143 | 10.4% | 1.3% |
| Leak/splashthe device leaked | 90 | 6.5% | 3.9% |
| Gas/air leak | 83 | 6% | 1.7% |
| Material split, cut or torn | 53 | 3.8% | 2.5% |
| Decrease in pressure | 48 | 3.5% | 0.5% |
| Detachment of device component | 43 | 3.1% | 5.3% |
| Difficult to insertthe device was hard to insert | 42 | 3% | 1.2% |
| Difficult to removethe device was hard to remove | 25 | 1.8% | 1.3% |
| Material deformation | 24 | 1.7% | 0.4% |
| Product quality problem | 23 | 1.7% | 0.2% |
| Insufficient device problem information | 19 | 1.4% | 0.6% |
| Noise, audible | 17 | 1.2% | 0.5% |
| Device packaging compromised | 12 | 0.9% | 0.4% |
| Human-device interface problem | 11 | 0.8% | 0.1% |
| Deflation problem | 9 | 0.7% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 6 | 0.4% | 0.2% |
| Hole in material | 6 | 0.4% | 0.2% |
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 |
|---|---|---|
| No patient involvement | 21 | 1.5% |
| Hemorrhage/blood loss/bleeding | 10 | 0.7% |
| Tissue breakdown | 10 | 0.7% |
| Tissue damage | 7 | 0.5% |
| Laceration(s) | 5 | 0.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.3% |
| Device embedded in tissue or plaque | 4 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 4 | 0.3% |
| Injurya physical injury | 3 | 0.2% |
| Blood loss | 1 | 0.1% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.1% |
| Hernia | 1 | 0.1% |
| Incontinence | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Perforation | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Spacemaker | Product code GCJ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,379 | 84,093 | 26,136,888 |
| Share of that pool | — | 1.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 3% | 8.3% | 36.2% |
| Classified as malfunction | 97% | 90.1% | 62.3% |
| Filed by the manufacturer | 96.9% | 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% |
| 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% |
| Protack | 801 | 44 | 0.1% |
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 Spacemaker reports
How many FDA reports name Spacemaker?
1,379 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 146 in the latest 12 months.
What kinds of events are reported?
malfunction (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (42.7%), inflation problem (37%), detachment of device or device component (13.8%), packaging problem (10.4%) and leak/splash (6.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Spacemaker 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.