FDA Adverse Event
Malfunction
Summary report: N
3.5MM 90? SERFAS ENERGY PROBE
MDR report key: 2240901
·
Received August 8, 2011
Report
- Report Number
- 2648666-2011-00185
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 20, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE TIP BROKE OFF IN THE PT. IT WAS FURTHER REPORTED THAT AFTER 45 MINUTES THE TIP WAS EXTRACTED FROM THE PT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 90? SERFAS ENERGY PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 11049AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |