FDA Adverse Event
Injury
Summary report: N
CIRCULAR STAPLER, 29MM DIGITAL LOADING UNIT
MDR report key: 1274444
·
Received December 29, 2008
Report
- Report Number
- 2532140-2008-00181
- Event Type
- Injury
- Date Received
- December 29, 2008
- Date of Event
- November 14, 2007
- Report Date
- November 14, 2007
- Manufacturer
- POWER MEDICAL INTERVENTIONS
- Product Code
- GDW
- PMA / PMN Number
- K032701
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CS33 WERE RETURNED AND EVALUATED ONE FROM LOT LC-000396 AND ONE FROM LOT LC-000395. BOTH DEVICES HAD NO DAMAGE AND FIRED ACCEPTABLE STAPLE FORMATION AND TRANSACTION. THE EXPIRATION DATE FOR LC-000396 IS 07/2008. THE MANUFACTURING DATE FOR LC-000396 IS 07/2006.
Description of Event or Problem · 1
A DEVICE WAS USED DURING A LOWER ANTERIOR RESECTION AND THE DEVICE WOULD NOT GET INTO FIRING RANGE. THE SURGEON ATTEMPTED TO OPEN THE DEVICE AND WAS ABLE TO REMOVE WITH THE MANUAL RELEASE. ANOTHER DEVICE WAS USED, WHICH REQUIRED THE ABDOMEN TO BE REOPENED. THERE WERE NO ADVERSE IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCULAR STAPLER, 29MM DIGITAL LOADING UNIT | STAPLE, IMPLANTABLE | GDW | POWER MEDICAL INTERVENTIONS | LC-000396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | POWER EXTENDER CURVED| PEC200 |