FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE LINEAR CUTTER
MDR report key: 227553
·
Received June 14, 1999
Report
- Report Number
- 1527736-1999-03374
- Event Type
- Malfunction
- Date Received
- June 14, 1999
- Report Date
- May 20, 1999
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THAT THE STAPLER WOULD NOT FIRE. A NEW STAPLE CARTRIDGE WAS INSERTED INTO THE INSTRUMENT AND FIRED PROPERLY. ONLY THE TCR55 STAPLE CARTRIDGE WAS SAVED. IT WAS NOTED THAT THE ORANGE PROXIMAL STAPLER DRIVERS WERE VISABLE ON THE 1ST (2) ROWS OF THE CARTRIDGE. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE LINEAR CUTTER | LINEAR CUTTERS - CONVENTIONAL | GAG | ETHICON ENDO-SURGERY - ALB | NA | M4DF96 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |