FDA Adverse Event
Malfunction
Summary report: N
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
MDR report key: 1034032
·
Received April 24, 2008
Report
- Report Number
- 2648666-2008-00048
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 27, 2008
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ON GOING. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
SALES REP REPORTED THAT DURING A CASE, THE PROBE, WENT OFF ON A PATIENTS JOINT WITHOUT ANY OF THE STAFF ACTIVATING IT. THE SAME HAPPENS WITH, THE NUMBERS THAT SHOW ON THE SCREEN CYCLES WITHOUT ANYONE CONTROLLING IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM 90-S SERFAS ENERGY SUCTION PROBE | SUCTION PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 0801AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |