FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL COAGULATING SHEARS WITH SCISSORGRIP
MDR report key: 192834
·
Received October 20, 1998
Report
- Report Number
- 1527736-1998-03062
- Event Type
- Malfunction
- Date Received
- October 20, 1998
- Date of Event
- September 22, 1998
- Report Date
- September 22, 1998
- Manufacturer
- POST SURGICAL MFG, INC.
- 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 A CS1S WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE JAW WOULD NOT CLOSE CORRECTLY. A NEW BLADE 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 COAGULATING SHEARS WITH SCISSORGRIP | ULTRASONIC-SURGERY DEVICE | LFL | POST SURGICAL MFG, INC. | NA | L4A93F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |