FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI
MDR report key: 293557
·
Received August 30, 2000
Report
- Report Number
- 1527736-2000-04090
- Event Type
- Malfunction
- Date Received
- August 30, 2000
- Report Date
- August 9, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A GASTRECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE LCSK5 SCISSORS DID NOT COAGULATE THE TISSUE EVEN THOUGH THE DEVICE WAS ASSEMBLED CORRECTLY. ANOTHER INSTRUMENT 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 | HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI | ULTRASONIC-SURGERY DEVICES - ENDOSC | LFL | ETHICON ENDO-SURGERY - ALB | NA | N4H244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |