FDA Adverse Event
Other
Summary report: N
APSII FOOTSWITCH, STANDARD
MDR report key: 1012367
·
Received March 11, 2008
Report
- Report Number
- 1220246-2008-00035
- Event Type
- Other
- Date Received
- March 11, 2008
- Date of Event
- January 15, 2008
- Report Date
- February 12, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED FOR EVAL, BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DID NOT STOP DURING SURGERY. THE DEVICE HAD TO BE UNPLUGGED TO STOP IT. ANOTHER PEDAL WAS USED TO COMPLETE THE CASE. THE SURGERY WAS DELAYED OVER 30 MINS BUT NO ADD'L ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. NO FURTHER PT INFO WAS PROVIDED BY THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APSII FOOTSWITCH, STANDARD | FOOTSWITCH | HWE | ARTHREX, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |