FDA Adverse Event
Malfunction
Summary report: N
CAST CUTTER, 8 FOOT CORD
MDR report key: 1924812
·
Received December 10, 2010
Report
- Report Number
- 1811755-2010-01995
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- LGH
- PMA / PMN Number
- PRE AMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND THE COMPLAINT WAS DUPLICATED. THE CAUSE IS MOT LIKELY DUE TO CUTS IN THE CORD AND EXPOSED WIRING. THE PRODUCT HAS BEEN DEEMED OBSOLETE BY THE MFR FOR NEW BUILD PRODUCTION.
Description of Event or Problem · 1
IT WAS REPORTED, THE CAST CUTTER WAS SPARKING WHILE TESTING. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAST CUTTER, 8 FOOT CORD | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | LGH | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |