FDA Adverse Event
Malfunction
Summary report: N
3.5MM RESECTOR CUTTER (5BX)
MDR report key: 1696587
·
Received May 10, 2010
Report
- Report Number
- 2648666-2010-00221
- Event Type
- Malfunction
- Date Received
- May 10, 2010
- Date of Event
- April 29, 2010
- Report Date
- April 29, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- FZT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SHAVER BLADE WAS FLAKING DURING USE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM RESECTOR CUTTER (5BX) | CUTTER | FZT | STRYKER ENDOSCOPY PUERTO RICO | 10083CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |