FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
MDR report key: 2191821
·
Received July 29, 2011
Report
- Report Number
- 1219930-2011-00626
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 21, 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: LAPAROSCOPIC KIDNEY SURGERY. ACCORDING TO THE RPTR: CUTTING WAS DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT | DISPOSABLE SURGICAL DEVICE | LFL | UNITED STATES SURGICAL | N1B0252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |