FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS, KNI
MDR report key: 298106
·
Received September 26, 2000
Report
- Report Number
- 1527736-2000-04623
- Event Type
- Malfunction
- Date Received
- September 26, 2000
- Report Date
- August 28, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE LCSK5, USED WITH A HPTUV, HAD NO FUNCTION. 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 |