FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES
MDR report key: 726052
·
Received June 8, 2006
Report
- Report Number
- 1527736-2006-02641
- Event Type
- Malfunction
- Date Received
- June 8, 2006
- Date of Event
- April 26, 2006
- Report Date
- April 26, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K990430
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
H6 CODE 400: THE ANALYSIS RESULTS CONFIRMED THAT THE HAND PIECE WAS RETURNED WITH THE 4-40 STUD BROKEN. NO TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION. 510(K) NUMBER IS K990430.
Description of Event or Problem · 1
THE 440 STUD IS MISSING ON THE HANDPIECE. THE CUSTOMER NOTICED THIS UPON UNWRAPPING THE STERILE PACK BEFORE A CASE. THE STUD WAS MISSING AND A FEMALE THREADED WHOLE WAS LEFT IN ITS PLACE. THE CUSTOMER USED ANOTHER HANDPIECE FOR THE PROCEDURE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES | LFL | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | GENERATOR. |