ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10366)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10366) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: PERMANENT CAUTERY SPATULA; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | PERMANENT CAUTERY SPATULA |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10366 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "NO PROTECTIVE COATING ON THE TIP OF THE SPATULA". THE INSTRUMENT WAS FOUND TO HAVE A MISSING/BROKEN SLEEVE. A BROKEN PIECE IS MISSING AS A RESULT OF BREAKAGE. THE SIZE OF MISSING PIECE IS APPROXIMATELY .32¿ |
| Source | openFDA MAUDE (device adverse events) |
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