FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS
MDR report key: 183304
·
Received August 18, 1998
Report
- Report Number
- 1527736-1998-02508
- Event Type
- Malfunction
- Date Received
- August 18, 1998
- Date of Event
- July 27, 1998
- Report Date
- August 4, 1998
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A TSB35 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE JAW WOULD NOT OPEN, SINCE THE ANVIL DISLODGED. A NEW STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS | LINEAR CUTTER | KOG | ETHICON ENDO-SURGERY | NA | K48N0D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |