FDA Adverse Event
Malfunction
Summary report: N
LOANER CORDLESS DRIVER 2
MDR report key: 1841970
·
Received August 24, 2010
Report
- Report Number
- 1811755-2010-01002
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- July 25, 2010
- Report Date
- July 27, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HXX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN AFTER A SURGICAL PROCEDURE. THERE HAS BEEN NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOANER CORDLESS DRIVER 2 | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | HXX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |