FDA Adverse Event
Malfunction
Summary report: N
OPT BL VP V2 5MM STD W/FX
MDR report key: 3173503
·
Received June 12, 2013
Report
- Report Number
- 1219930-2013-00444
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 23, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GCJ
- PMA / PMN Number
- K112349
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE UPPER SEAL OF THE TROCAR DETACHED AND WAS RESTING ABOVE THE BLUE DUCKBILL SEAL. THIS DID NOT FALL INTO THE PATIENT'S CAVITY. THE TROCAR WAS REMOVED AND A NEW ONE WAS OPENED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265352 | OPT BL VP V2 5MM STD W/FX | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3D0584HX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |