FDA Adverse Event
Malfunction
Summary report: N
DEROYAL
MDR report key: 2990080
·
Received February 26, 2013
Report
- Report Number
- 1060680-2013-00002
- Event Type
- Malfunction
- Date Received
- February 26, 2013
- Date of Event
- January 10, 2013
- Report Date
- February 4, 2013
- Manufacturer
- SWANN MORTON, LTD.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVENT OR PROBLEM: THE HOSPITAL REPORTED THAT 2 ON THS PRIOR TO THE DATE OF THE EVENT, THE KNIFE BLADE BROKE WHILE BEING REMOVED FROM THE HANDLE. DEROYAL: THE DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION AND ROOT CAUSE INVESTIGATION. A SUPPLIER CORRECTIVE ACTION REQUEST WAS SUBMITTED TO SWANN MORTON FOR THEM TO EVALUATE THIS REPORTED EVENT.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT 2 MONTHS PRIOR TO THE DATE OF THE EVENT, THE KNIFE BLADE BROKE WHILE BEING REMOVED FROM THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 81198 | DEROYAL | GES- BLADE, SCALPEL | GES | SWANN MORTON, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |