FDA Adverse Event
Malfunction
Summary report: N
3.5MM 90 DEGREE SERFAS ENERGY PROBE
MDR report key: 2221414
·
Received August 16, 2011
Report
- Report Number
- 2648666-2011-00196
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 2, 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
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DURING AN ARTHROSCOPIC PROCEDURE ON THE MENISCUS, THE TIP OF THE UNIT FELL OFF INTO THE PT. IT WAS FURTHER REPORTED THAT THE TIP WAS RETRIEVED FROM THE PT. THE DOCTOR REQUESTED A REVIEW OF THE STRENGTH OF THE TIP OF THE UNIT AND INDICATED THAT THE TIP WAS VERY WEAK AND EASY TO BREAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 90 DEGREE SERFAS ENERGY PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 1132AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |