FDA Adverse Event
Injury
Summary report: N
ABS FIXATION DEVICE W/30 TACKS
MDR report key: 3232249
·
Received July 8, 2013
Report
- Report Number
- 1219930-2013-00484
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 25, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K071061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4).
Description of Event or Problem · 1
PROCEDURE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE TOOL BROKE DURING USE. THE DIFFICULTY RESULTED IN AN OPEN PROCEDURE. THERE WAS NO UNANTICIPATED TISSUE AND BLOOD LOSS, THE PT IS IN GOOD CONDITION, THERE WAS NO COMPLICATION AND THE OPERATION TIME DID NOT EXTEND. NO FRAGMENT OF THE DEVICE FELL INTO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310033 | ABS FIXATION DEVICE W/30 TACKS | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY US SURGICAL | NIK0864X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |