FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55
MDR report key: 726708
·
Received June 15, 2006
Report
- Report Number
- 1527736-2006-02724
- Event Type
- Malfunction
- Date Received
- June 15, 2006
- Date of Event
- May 25, 2006
- Report Date
- May 25, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. (510(K)#K002906)
Description of Event or Problem · 1
DURING A UNK PROCEDURE THE THREADED STUD BROKE ON THE HANDPIECE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.
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 |