FDA Adverse Event
Malfunction
Summary report: N
+IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS
MDR report key: 1250833
·
Received November 25, 2008
Report
- Report Number
- 2647580-2008-00662
- Event Type
- Malfunction
- Date Received
- November 25, 2008
- Date of Event
- October 28, 2008
- Report Date
- October 31, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GCJ
- PMA / PMN Number
- K981941
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 11/24/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THE SURGEON FOUND SMALL ORANGE PIECES FALLING OUT OF THE TROCAR PRIOR THE PROCEDURE. THIS DEVICE WAS NOT USED DURING THE PROCEDURE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | PONCE - USS | P8B1072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |