FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
MDR report key: 2220097
·
Received August 15, 2011
Report
- Report Number
- 1219930-2011-00684
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 5, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- LFL
- PMA / PMN Number
- K971861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: TWO OF THE DEVICES WOULD NOT HOLD AND CUT TISSUE AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. OOZING OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT | DISPOSABLE SURGICAL DEVICE | LFL | UNITED STATES SURGICAL | N0M0323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |