VAPR HOOK ELECTRODE Adverse Event — Malfunction (MDR 1221934-2008-00058)
VAPR HOOK ELECTRODE Adverse Event — Malfunction (MDR 1221934-2008-00058) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VAPR HOOK ELECTRODE; Generic name: ELECTROSURGICAL, CUTTING & COAGULATING; Manufacturer: DEPUY MITEK.
| Device | VAPR HOOK ELECTRODE |
|---|---|
| Generic name | ELECTROSURGICAL, CUTTING & COAGULATING |
| Manufacturer | DEPUY MITEK |
| Report number | 1221934-2008-00058 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-01 |
| Report source | Other, Health Professional, User facility |
| Narrative | RECEIVED A MEDWATCH 3500A FROM THE FDA ALERTING US THAT A USER FACILITY REPORTED HAVING HAD THE HOOK OF A HOOK ELECTRODE BREAK OFF INTO A PT'S JOINT SPACE DURING A PROCEDURE. THE FRAGMENT WAS RECOVERED FROM THE BODY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THIS ISSUE WAS NOT ORIGINALLY REPORTED TO MITEK BY THE USER FACILITY, THEY SUBMITTED A 3500 TO TH |
| Source | openFDA MAUDE (device adverse events) |
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