FDA Adverse Event
Malfunction
Summary report: N
5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT
MDR report key: 1978644
·
Received January 10, 2011
Report
- Report Number
- 2936485-2011-00013
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 19, 2010
- Report Date
- December 28, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. A SIMILAR PRODUCT WITH SERIAL NUMBER 060410-02 WAS ALSO IMPLICATED IN THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE UNIT WAS USED, THE INSULATION BURNED AWAY. IT WAS FURTHER REPORTED THAT UPON EXAMINATION OF THE UNIT, THE INSULATION WAS NOT INTACT AND THAT IT WAS CRACKED AND BURNT. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT | SUCTION/IRRIGATION | HRX | STRYKER ENDOSCOPY SAN JOSE | 090909-05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |