FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
MDR report key: 374487
·
Received January 4, 2002
Report
- Report Number
- 1527736-2002-00003
- Event Type
- Malfunction
- Date Received
- January 4, 2002
- Date of Event
- October 31, 2001
- Report Date
- December 13, 2001
- Manufacturer
- ETHICON ENDO-SURGERY - ALB
- Product Code
- LFL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE WAS USED DURING A LAPAROSCOPIC ADRENAL PROCEDURE. THE DEVICE APPEARED TO STOP FUNCTIONING PART WAY THROUGH THE PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT 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 | P4LY2X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |