FDA Adverse Event
Malfunction
Summary report: N
SERFAS ENERGY SUPER 90-S
MDR report key: 2053355
·
Received March 16, 2011
Report
- Report Number
- 2648666-2011-00072
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 3, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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 DURING A CASE, THE TIP OF THE UNIT BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERFAS ENERGY SUPER 90-S | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 10354AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |