FDA Adverse Event
Injury
Summary report: N
ENDOPATH STEALTH CIR STAPLER
MDR report key: 1131523
·
Received August 14, 2008
Report
- Report Number
- 3005075853-2008-01197
- Event Type
- Injury
- Date Received
- August 14, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- OCW
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 08/14/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PROD INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MFG RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH STEALTH CIR STAPLER | * | OCW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |