FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI
MDR report key: 296081
·
Received September 12, 2000
Report
- Report Number
- 1527736-2000-04306
- Event Type
- Malfunction
- Date Received
- September 12, 2000
- Date of Event
- August 23, 2000
- Report Date
- August 25, 2000
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE TWO LCSK5 AND THE ONE HP053 WERE USED DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE. IT WAS REPORTED THAT THE FIRST INSTRUMENT WENT TO SOLID TONE DURING THE TRANSECTION OF THE "IP". A SECOND INSTRUMENT WAS PULLED WHICH WENT SOLID TONE ON THE CULPOTOMIZER. A THIRD LCSK5 WAS PULLED TO COMPLETE THE PROCEDURE. A NEW LUKE HANDPIECE WAS USED WITH THESE INSTRUMENTS AND HAD TO BE REPLACED AFTER THE SECOND BLADE WENT SOLID TONE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL LAPAROSCOPIC COAGULATING SHEARS, KNI | ULTRASONIC-SURGERY DEVICES - ENDOSCOPIC | LFL | ETHICON ENDO-SURGERY - ALB | NA | N4HY67 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |