FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT
MDR report key: 1112623
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01053
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 22, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE ACTIVE BLADE BROKE OFF. IT IS UNK IF IT FELL INTO THE PT, HOWEVER, THE PIECE IS PRESENT WITH THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT | GEI | ETHICON ENDO-SURGERY, LLC | NA | E4KT86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |