FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI
MDR report key: 293555
·
Received August 30, 2000
Report
- Report Number
- 1527736-2000-04091
- Event Type
- Malfunction
- Date Received
- August 30, 2000
- Report Date
- August 3, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) LCSK5 WERE USED DURING AN UNKNOWN PROCEDURE. NO OTHER DETAIL REGARDING THIS CASE.
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 | N4H18W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |