FDA Adverse Event
Other
Summary report: N
GELPOINT SYSTEM, 100MM
MDR report key: 1565284
·
Received December 17, 2009
Report
- Report Number
- 2027111-2009-00136
- Event Type
- Other
- Date Received
- December 17, 2009
- Date of Event
- December 14, 2009
- Report Date
- December 17, 2009
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET RETURNED FOR EVALUATION. A FINAL REPORT WILL BE ISSUED UPON RECEIPT OF PRODUCT AND COMPLETION OF EVALUATION.
Description of Event or Problem · 1
"EVALUATION OF SINGLE PORT AND TO DECIDE WHICH ONE TO BE USED IN HOSP (GELPOINT OF SILS). FOUR 4 TROCARS WERE USED INSTEAD OF 3 AND THAT WAS AN ADVANTAGE OVER SILS (COVIDIEN), HE USED ALSO THE ROTICULATOR ENDO GRASP (COVIDIEN). DURATION OF CASE: 68 MINUTES. PROBLEM 1: LEAK FROM GEL SURROUNDING THE TROCARS WHEN MANIPULATING. PROBLEM 2: THE SURGEON FOUND SMALL PORTIONS OF GEL INSIDE THE ABDOMEN. FACTS: THE TROCAR INNER RING MOVES INSIDE THE GEL, AS WELL PORTIONS OF GEL WERE DRAGGED INSIDE CAUSED BY HAND INSTRUMENT INSERTIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GELPOINT SYSTEM, 100MM | GCJ | APPLIED MEDICAL RESOURCES | CNGL2 | 10099025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |