FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55
MDR report key: 725953
·
Received June 7, 2006
Report
- Report Number
- 1527736-2006-02596
- Event Type
- Malfunction
- Date Received
- June 7, 2006
- Report Date
- March 16, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- k002906
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A CRACKED NOSE CONE. IT WAS TESTED ON A GENERATOR AND NO ERROR CODES WERE FOUND. HOWEVER, THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. (510(K)#K002906)
Description of Event or Problem · 1
DURING AN UNK PROCEDURE, ERROR CODE 3. THERE WAS NO REPORTED PATIENT CONSEQUENCE. IT WAS NOT NOTED HOW THE PROCEURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 | LFL | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | GENERATOR |