FDA Adverse Event
Injury
Summary report: N
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
MDR report key: 2112329
·
Received May 24, 2011
Report
- Report Number
- 2648666-2011-00144
- Event Type
- Injury
- Date Received
- May 24, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 29, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A REVISION ACL RECONSTRUCTION, THE TIP OF THE UNIT CAME OFF INSIDE THE KNEE OF THE PT. IT WAS FURTHER REPORTED THAT THE TIP COULD NOT BE LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 90-S SERFAS ENERGY SUCTION PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 0000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |