FDA Adverse Event
Malfunction
Summary report: N
3.5 MM 90 DEGREE SERFAS ENERGY PROBE
MDR report key: 2133287
·
Received May 12, 2011
Report
- Report Number
- 2648666-2011-00135
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 24, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING KNEE SURGERY, THE TIP OF THE UNIT BROKE OFF INSIDE THE PT. THE TIP WAS REMOVED ARTHROSCOPICALLY FROM THE PT AND THE SURGERY WAS COMPLETED. IT WAS FURTHER REPORTED THAT DURING THE SURGERY, THE UNIT WAS BENT SEVERAL TIMES NEAR THE TIP AND THE DOCTOR WANTED TO KNOW IF REPEATED BENDING OF THE UNIT LED TO THE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5 MM 90 DEGREE SERFAS ENERGY PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 10336AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |