FDA Adverse Event
Other
Summary report: N
APS II SMALL SHAVER HANDPIECE, FOOTSWITCH CONTROL
MDR report key: 1001404
·
Received February 23, 2008
Report
- Report Number
- 1220246-2008-00029
- Event Type
- Other
- Date Received
- February 23, 2008
- Date of Event
- January 10, 2008
- Report Date
- January 28, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE DID NOT WORK DURING THE SURGERY. THE HANDPIECE WAS CHANGED TO COMPLETE THE CASE. A DELAY OF OVER 30 MINS WAS REPORTED BUT NO ADVERSE CONSEQUENCES RESULTED FROM THE EVENT. NO FURTHER PT INFO IS AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APS II SMALL SHAVER HANDPIECE, FOOTSWITCH CONTROL | SHAVER HANDPIECE | HRX | ARTHREX, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |