FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 2860599
·
Received December 5, 2012
Report
- Report Number
- 2134070-2012-00306
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 15, 2012
- Manufacturer
- STERILMED, INC.
- Product Code
- NUJ
- PMA / PMN Number
- K012598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WAS REPORTED TO BE DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY, THE JAWS OF THE DEVICE COULD NOT OPEN AND RELEASE THE TISSUE. NO INFORMATION WAS AVAILABLE AS TO HOW THE DEVICE WAS REMOVED. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED A THE USER FACILITY DUE TO CONTAMINATION WITH (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | NUJ | STERILMED, INC. | VALLS1020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |