FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
MDR report key: 3080699
·
Received April 9, 2013
Report
- Report Number
- 1219930-2013-00233
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 18, 2013
- Manufacturer
- COVIDIEN FORMERLY US SUR
- Product Code
- LFL
- PMA / PMN Number
- K971861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE DEVICE WOULD NOT GRASP AND CUT THE TISSUE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS OOZING. THERE WAS NOT TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. NOTHING FELL INTO THE PT'S CAVITY. OPERATING ROOM TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144654 | AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT | DISPOSABLE SURGICAL DEVICE | LFL | COVIDIEN FORMERLY US SUR | N2H0269X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |