FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 298254
·
Received September 25, 2000
Report
- Report Number
- 1527736-2000-04571
- Event Type
- Malfunction
- Date Received
- September 25, 2000
- Date of Event
- September 13, 2000
- Report Date
- September 13, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE (1) LCSC5 WAS USED DURING A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS WORKING FINE THROUGHOUT THE CASE. THE LAST STRETCH OF TISSUE TO CUT/COAGULATE THE BLADE GAVE A STILL TONE. THE STAFF TRIED EVERYTHING-REMOVING ESCHAR TISSUE, DROWNING IT WITH SALINE TO FREE ANY JAMMED TISSUE, DISASSEMBLY AND REASSEMBLY. NOTHING ENABLED THE STAFF TO REVIVE THE INSTRUMENT. THE CASE WAS FINISHED WITH ELECTROCAUTERY REUSABLE SCISSORS.
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 |