FDA Adverse Event
Death
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
MDR report key: 1127487
·
Received August 20, 2008
Report
- Report Number
- 3005075853-2008-01300
- Event Type
- Death
- Date Received
- August 20, 2008
- Date of Event
- June 5, 2008
- Report Date
- July 28, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- OCW
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 8/20/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A COLON RESECTION. THE DEVICE WORKED PROPERLY. UNK IF STAPLE LINE WAS INSPECTED AT TIME OF PROCEDURE. IT WAS REPORTED THAT A STAPLE LINE LEAK OCCURRED POST OPERATIVELY AND THE PT EXPIRED DUE TO PERITONITIS. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM | OCW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |