FDA Adverse Event
Malfunction
Summary report: N
FMS HANDPIECE INTERFACE CONTROL
MDR report key: 1302567
·
Received January 29, 2009
Report
- Report Number
- 1221934-2009-00035
- Event Type
- Malfunction
- Date Received
- January 29, 2009
- Date of Event
- January 15, 2009
- Report Date
- January 15, 2009
- Manufacturer
- DEPUY MITEK
- Product Code
- HRX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A FAILURE ANALYSIS. THE RESULTS OF THE INVESTIGATION WILL BE THE SUBJECT MATTER OF THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING THAT THIS PARTICULAR FMS HANDPIECE INTERFACE CONTROL UNIT IS PICKING UP SIGNALS FROM AN "ARTHROCARE GENERATOR" THAT IS ABOUT 2-3 FEET FROM THE CONTROLLER'S OPTICAL COUPLER. OTHER FMS HICS DO NOT APPEAR TO HAVE THIS ISSUE, BUT THIS ONE SEEMS PARTICULARLY SENSITIVE. THERE WERE NO PATIENT CONSEQUENCES DUE TO THIS ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMS HANDPIECE INTERFACE CONTROL | FLUID MANAGEMENT TOOL | HRX | DEPUY MITEK | 282005 | 07104281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |