FDA Adverse Event
Death
Summary report: N
PROXIMATE LINEAR CUTTER
MDR report key: 293444
·
Received August 30, 2000
Report
- Report Number
- 1527736-2000-04105
- Event Type
- Death
- Date Received
- August 30, 2000
- Date of Event
- July 27, 2000
- Report Date
- August 7, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A GASTRIC BYPASS. IT WAS REPORTED BY THE REP THAT THE ANASTOMOSIS WAS PERFORMED WITH THE TLC75 INSTRUMENT. THE PT EXPIRED ON DAY 2 POSTOPERATIVELY. THE INTITIAL AUTOPSY REPORT IDENTIFIES CAUSE DUE TO LEAK AT JEJUNOSTOMY. THE DEVICE WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE LINEAR CUTTER | LINEAR CUTTERS - CONVENTIONAL | GAG | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |