FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
MDR report key: 725917
·
Received June 7, 2006
Report
- Report Number
- 1527736-2006-02593
- Event Type
- Malfunction
- Date Received
- June 7, 2006
- Date of Event
- May 23, 2006
- Report Date
- May 26, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- k002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION NOT AVAILABLE; DEVICE NOT RETURNED FOR ANALYSIS. (510(K)#K002981)
Description of Event or Problem · 1
DURING AN UNK PROCEDURE, AN ERROR CODE 5 WAS INDICATED, WITH GENERATOR AND HAND PIECE. THERE WAS A SCRATCH ON THE BLADE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURG DEV, CURVED SHEARS, OPEN | GEI | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | HANDPIECE| GENERATOR |