FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX ULTRA SHEARS LONG
MDR report key: 3969306
·
Received May 2, 2014
Report
- Report Number
- 1219930-2014-00348
- Event Type
- Malfunction
- Date Received
- May 2, 2014
- Date of Event
- February 24, 2014
- Report Date
- April 3, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- LFL
- PMA / PMN Number
- K971861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER: IT IS UNKNOWN WHETHER THERE WAS BLEEDING OF 500CC OR MORE. IT IS UNKNOWN WHETHER THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. IT IS UNKNOWN WHETHER THERE WAS ANY UNANTICIPATED TISSUE LOSS. IT IS UNKNOWN WHETHER THE INCISION WAS EXTENDED BY MORE THAN ONE INCH. IT IS UNKNOWN WHETHER THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
Description of Event or Problem · 1
PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE THE DISSECTION DID NOT WORK PROPERLY. ADDITIONAL QUESTIONS HAVE BEEN ASKED OF THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265605 | AUTOSONIX ULTRA SHEARS LONG | AUTOSONIX SHEARS | LFL | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3E0059X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |