FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE
MDR report key: 1190769
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03489
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 22, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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, THERE WAS AN INSTRUMENT ERROR SO THEY TRIED TO TROUBLESHOOT IT, BUT WHILE THEY WERE TRYING TO TEST IT, THE BLADE FELL OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE | NONE | GEI | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | E4KV56 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |