FDA Adverse Event
Malfunction
Summary report: N
OPT BL VP V2 5MM STD W/FX
MDR report key: 3100071
·
Received April 29, 2013
Report
- Report Number
- 1219930-2013-00292
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY US SUR
- Product Code
- GCJ
- PMA / PMN Number
- K112349
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER; PART OF THE SEAL OF THE TROCAR WAS PUSHED THROUGH THE CANNULA ON REINTRODUCTION OF THE TROCAR. THE SEAL BUT DID NOT FALL INTO THE PT CAVITY. THERE WAS NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR IRREVERSIBLE DAMAGE AS RESULT OF THIS PROBLEM. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184287 | OPT BL VP V2 5MM STD W/FX | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN LP, FORMERLY US SUR | N3B0056X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |