FDA Adverse Event
Malfunction
Summary report: N
AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT
MDR report key: 4123436
·
Received September 26, 2014
Report
- Report Number
- 1219930-2014-00891
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 11, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP. LIVING DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE TISSUE WAS NOT CUTTING COMPLETELY AND THE GRASPING FORCE WAS NOT ENOUGH AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600086 | AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT | AUTOSONIX SHEARS | LFL | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 012001 | N3J1024X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |