FDA Adverse Event
Malfunction
Summary report: N
VISIPORT PLUS 5-11MM WITH FIXATION
MDR report key: 2061392
·
Received March 17, 2011
Report
- Report Number
- 2647580-2011-00188
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- September 28, 2010
- Report Date
- February 22, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K935086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: TIP OF VISIPORT FAILED DURING INITIAL APPLICATION. THE END BROKE OFF INTO 2 SEPARATE PIECES. PIECES WERE RETRIEVED FROM SURGICAL WOUND. IT WAS UNKNOWN IF THERE WAS ANY BLEEDING IN EXCESS OF 250CC, IF THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES OR IF ANY TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS OCCURRED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIPORT PLUS 5-11MM WITH FIXATION | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P8F0138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |