FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM
MDR report key: 1150956
·
Received August 28, 2008
Report
- Report Number
- 3005075853-2008-01408
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT 08/28/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES DID NOT COMPLETE AS INTENDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |