FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 296563
·
Received September 13, 2000
Report
- Report Number
- 1527736-2000-04330
- Event Type
- Malfunction
- Date Received
- September 13, 2000
- Date of Event
- August 29, 2000
- Report Date
- September 1, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- 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 (1) DEVICE WAS USED DURING A LAPAROSCOPIC COLECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE LCSC5, USED WITH A HP050, EMITTED AN ERROR ALARM. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.
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 | N4J63W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |