FDA Adverse Event
Malfunction
Summary report: N
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
MDR report key: 2842403
·
Received October 22, 2012
Report
- Report Number
- 2648666-2012-00340
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- October 3, 2012
- Report Date
- October 3, 2012
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- PMA / PMN Number
- K041810
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE METALLIC TIP OF THE PROBE UNIT GOT DETACHED INTO THE PATIENT'S SHOULDER. THE FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 90-S SERFAS ENERGY SUCTION PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 12159AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |