FDA Adverse Event
Malfunction
Summary report: N
4.0MM TOMCAT CUTTER, FORMULA (5BX)
MDR report key: 1633338
·
Received March 10, 2010
Report
- Report Number
- 2648666-2010-00128
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- February 19, 2010
- Report Date
- February 23, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- FZT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT LARGE AMOUNTS OF METAL FILLINGS WERE LEFT IN THE JOINT SPACE AFTER USE AND WERE WASHED OUT WITH COPIOUS AMOUNTS OF FLUIDS. AS A RESULT OF THIS, THE SURGEON DID NOT WISH TO USE THE BLADES IN THIS LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM TOMCAT CUTTER, FORMULA (5BX) | CUTTER | FZT | STRYKER ENDOSCOPY PUERTO RICO | 09351CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |