FDA Adverse Event
Death
Summary report: N
PROXIMATE LINEAR CUTTER RELOAD THICK
MDR report key: 281838
·
Received June 14, 2000
Report
- Report Number
- 1527736-2000-02580
- Event Type
- Death
- Date Received
- June 14, 2000
- Date of Event
- May 20, 2000
- Report Date
- May 22, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) TCT75, (1) TLC55, (2) TRT75, AND (1) TRT55 WERE USED DURING A BOWEL PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SURGEON WAS USING TLC55 AND TCT75 TO RESECT BOWEL IN A TRAUMA CASE WHERE THERE WAS MUCH BLEEDING. THE GUNS WOULD NOT FIRE AND TIME WAS TAKEN TO RELOAD OR GET A NEW GUN. IT WAS AN EMERGENCY SITUATION AND THE BLEEDING CONTINUED. THE PT HAS EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE LINEAR CUTTER RELOAD THICK | LINEAR CUTTERS - CONVENTIONAL | GCJ | ETHICON ENDO-SURGERY, INC. | NA | N4GL88 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |