FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
MDR report key: 2822066
·
Received October 9, 2012
Report
- Report Number
- 1219930-2012-00813
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Date of Event
- September 21, 2012
- Report Date
- September 25, 2012
- Manufacturer
- COVIDIEN, FORMERLY US
- 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: LADG - LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE DID NOT CUT WELL FROM THE BEGINNING OF THE PROCEDURE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING, NO TISSUE DAMAGE, NO ADDITIONAL TISSUE LOSS. OPERATING ROOM TIME WAS NOT EXTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT | DISPOSABLE SURGICLA DEVICE | LFL | COVIDIEN, FORMERLY US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |