Devices › Laparoscope, general & plastic surgery
Device brand name · Disposable surgical access device
Spacemaker Preperitoneal Dist Balloon: medical device reports filed with FDA
612 reports name it, 2002–2017. Manufacturer given most often on reports: Covidien Formerly Ussc Puerto Rico. Product code GCJ.
- 612
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 95.8%
- 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 612 reports that name the brand "Spacemaker Preperitoneal Dist Balloon" (disposable surgical access device), received between January 2002 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 (95.8%) and injury (4.1%); 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 (44.1%), burst container or vessel (13.9%) and break (12.9%). The patient problems coded most often are foreign body, removal of, no patient involvement and hemorrhage/blood loss/bleeding. 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 Spacemaker Preperitoneal Dist Balloon 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 | 270 | 44.1% | 4.3% |
| Burst container or vessel | 85 | 13.9% | 0.8% |
| Breakthe device broke | 79 | 12.9% | 13.5% |
| Detachment of device component | 41 | 6.7% | 5.3% |
| Material rupture | 26 | 4.2% | 0.5% |
| Material separation | 25 | 4.1% | 1.4% |
| Replace | 25 | 4.1% | 12.3% |
| Balloon burst | 24 | 3.9% | 0.3% |
| Device, removal of (non-implant) | 19 | 3.1% | 0.8% |
| Balloon rupture | 14 | 2.3% | 0.2% |
| Component falling | 14 | 2.3% | 1.6% |
| Hole in material | 14 | 2.3% | 0.2% |
| Air leak | 13 | 2.1% | 2.2% |
| Difficult to removethe device was hard to remove | 11 | 1.8% | 1.3% |
| Torn material | 10 | 1.6% | 0.8% |
| Leak/splashthe device leaked | 9 | 1.5% | 3.9% |
| Split | 6 | 1% | 0.2% |
| Detachment of device or device componentpart of the device came off | 5 | 0.8% | 6% |
| Disengaged | 5 | 0.8% | 0.8% |
| Device, or device fragments remain in patient | 3 | 0.5% | 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 |
|---|---|---|
| Foreign body, removal of | 39 | 6.4% |
| No patient involvement | 26 | 4.2% |
| Hemorrhage/blood loss/bleeding | 25 | 4.1% |
| Tissue damage | 20 | 3.3% |
| Surgery, prolonged | 7 | 1.1% |
| Blood loss | 5 | 0.8% |
| Surgical procedure, additional | 4 | 0.7% |
| Device embedded in tissue or plaque | 3 | 0.5% |
| Nonresorbable materials, unretrieved in body | 3 | 0.5% |
| Surgical procedure | 2 | 0.3% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.2% |
| Hematuria | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Not applicable | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Spacemaker Preperitoneal Dist Balloon | Product code GCJ | All MAUDE reports |
|---|---|---|---|
| Reports | 612 | 84,093 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 4.1% | 8.3% | 36.2% |
| Classified as malfunction | 95.8% | 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 Spacemaker Preperitoneal Dist Balloon reports
How many FDA reports name Spacemaker Preperitoneal Dist Balloon?
612 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 (95.8%) and injury (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inflation problem (44.1%), burst container or vessel (13.9%), break (12.9%), detachment of device component (6.7%) and material rupture (4.2%). 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 Spacemaker Preperitoneal Dist Balloon 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.