FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
MDR report key: 3131813
·
Received April 30, 2013
Report
- Report Number
- 1219930-2013-00343
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 11, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- LFL
- PMA / PMN Number
- K971861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: AFTER SCREWING THE TRANSDUCER WITH TWEEZERS AND THEN IMMEDIATELY WITH A TORQUE WRENCH, IT BROKE THE PIVOT INSIDE. NO INJURY WAS REPORTED. THERE WAS NO PERMANENT DAMAGE. THE EVENT DID NOT PROLONG THE HOSPITAL STAY. THERE WAS NO BLEEDING IN EXCESS OF 500CC. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188873 | AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT | DISPOSABLE SURGICAL DEVICE | LFL | COVIDIEN, FORMERLY US SURGICAL | N2C0566X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |