FDA Adverse Event
Malfunction
Summary report: N
4.0 MM 90-S MAX SERFAS ENERGY SUCTION PROBE
MDR report key: 1021550
·
Received March 24, 2008
Report
- Report Number
- 2648666-2008-00032
- Event Type
- Malfunction
- Date Received
- March 24, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 25, 2008
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE TOP PORTION OF THE PORCELAIN CRACKED, AND FELL OFF INTO THE JOINT. ELECTRODE DISLODGED AND FELL INTO JOINT, DELAY SURGERY 5 MINS, NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0 MM 90-S MAX SERFAS ENERGY SUCTION PROBE | SUCTION PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 08010AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |