FDA Adverse Event
Malfunction
Summary report: N
5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
MDR report key: 1644549
·
Received March 10, 2010
Report
- Report Number
- 2648666-2010-00148
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- March 9, 2010
- Report Date
- March 10, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- FZT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD METAL FLAKING IN 4 OF THEIR LAST 5 SHOULDER PROCEDURES. ALLEGEDLY, THE SHAVER ALMOST APPEARS TO STUTTER OR SKIP. IT WAS FURTHER REPORTED THAT DIFFERENT HANDPIECES, FOOTPEDALS AND TPS CONSOLES WERE USED AND THE METAL IS STILL BEING SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) | CUTTER | FZT | STRYKER ENDOSCOPY PUERTO RICO | 10015CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |