FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 297861
·
Received September 21, 2000
Report
- Report Number
- 1527736-2000-04505
- Event Type
- Malfunction
- Date Received
- September 21, 2000
- Report Date
- August 31, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SOLID TONE WAS HEARD FROM THE HARMONIC SCALPEL. THE BLADE WAS REMOVED FROM THE HANDPIECE. A SECOND INSTRUMENT WAS OPENED AND USED TO COMPELTE THE CASE. THERE WAS NO CONSEQUENCE TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE | ULTRASONIC-SURGERY DEVICES - ENDOSC | LFL | ETHICON ENDO-SURGERY - ALB | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |