ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10391)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10391) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: PERMANENT CAUTERY HOOK; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | PERMANENT CAUTERY HOOK |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10391 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, OTHER |
| Narrative | (B)(4). INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INVOLVED WITH THIS COMPLAINT AND COMPLETED ITS EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE ALLEGED COMPLAINT OF AN ¿ELECTRIC ARC DURING A PROCEDURE AT THE HOOK BASE¿ OF THE INSTRUMENT. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON ONE OF THE DISTAL IDLER PULLEYS. THE CONDUCTOR C |
| Source | openFDA MAUDE (device adverse events) |
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