FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD UNIT
MDR report key: 217804
·
Received April 2, 1999
Report
- Report Number
- 1527736-1999-01915
- Event Type
- Malfunction
- Date Received
- April 2, 1999
- Date of Event
- February 25, 1999
- Report Date
- March 4, 1999
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) DEVICES WERE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT ON THE SECOND FIRING, THE INSTRUMENT BROKE AND WOULD NOT STAPLE THE TISSUE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD UNIT | LINEAR CUTTERS-ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |