FDA Adverse Event
Malfunction
Summary report: N
POWER LINEAR CUTTER RELOAD, 75 MM BLUE
MDR report key: 1180824
·
Received September 23, 2008
Report
- Report Number
- 2532140-2008-00065
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 27, 2008
- Report Date
- September 23, 2008
- Manufacturer
- POWER MEDICAL INTERVENTIONS
- Product Code
- GDW
- PMA / PMN Number
- K052415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PLCR75B WAS RETURNED AND EVALUATED. THERE WAS A JAMMED PUSHER IN THE RELOAD, RESULTING IN AN INCOMPLETE FIRING. PMI HAS IMPLEMENTED A CORRECTIVE ACTION REQUEST TO ADDRESS THIS FAILURE MODE. SEE SCANNED PAGES.
Description of Event or Problem · 1
WHILE USING A PLCR75B PARTIAL STAPLING OCCURRED, AND THE KNIFE BLADE WAS LEFT EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER LINEAR CUTTER RELOAD, 75 MM BLUE | STAPLE, IMPLANTABLE | GDW | POWER MEDICAL INTERVENTIONS | MT-000516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |