FDA Adverse Event
Malfunction
Summary report: N
RIGHT ANGLE LINEAR CUTTER, 30MM DLU
MDR report key: 1181059
·
Received September 29, 2008
Report
- Report Number
- 2532140-2008-00071
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 8, 2008
- Manufacturer
- POWER MEDICAL INTERVENTIONS
- Product Code
- GDW
- PMA / PMN Number
- K022313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RALC30V AND FS214 DEVICES WERE TESTED IN THE LAB AND PERFORMED AS INTENDED. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
AFTER FIRING THE RALC30V DEVICE, IT WAS NOTED THAT THE INSTRUMENT FAILED TO CUT TISSUE COMPLETELY AND UNDER FORMED STAPLES WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT ANGLE LINEAR CUTTER, 30MM DLU | STAPLE, IMPLANTABLE | GDW | POWER MEDICAL INTERVENTIONS | LC-000448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | IDRIVE INTELLIGENT DELIVERY SYSTEM CURVED |