ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10357)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10357) 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 | 2955842-2020-10357 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. THE PCH WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE BROKEN AT THE YAW PULLEY. IT WAS NOTED THE INSTRUMENT HAD 6 USES REMAINING. AS OF 04/09/2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDI |
| Source | openFDA MAUDE (device adverse events) |
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