FDA Adverse Event
Malfunction
Summary report: N
ENDOSCOPIC LINEAR CUTTER RELOAD, 45MM GREEN
MDR report key: 1222850
·
Received November 6, 2008
Report
- Report Number
- 2532140-2008-00087
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 9, 2008
- Manufacturer
- POWER MEDICAL INTERVENTIONS
- Product Code
- GDW
- PMA / PMN Number
- K052415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE IR45G WAS EVALUATED AND NO ABNORMALITIES WERE NOTED THAT WOULD HAVE CAUSED THE PARTIAL STAPLING AND CUTTING. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.
Description of Event or Problem · 1
DURING ONE FIRING OF THE IR45G, PARTIAL STAPLING AND MALFORMED STAPLES WERE OBSERVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSCOPIC LINEAR CUTTER RELOAD, 45MM GREEN | STAPLE, IMPLANTABLE | GDW | POWER MEDICAL INTERVENTIONS | PM-000334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |