ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10362)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10362) 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 | 2955842-2020-10362 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED ISSUE THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT ¿MOVES IN A DIFFERENT WAY INSTEAD OF INPUT GIVEN¿ BY THE SURGEON. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS TESTED ON AN IN-HOUSE SY |
| Source | openFDA MAUDE (device adverse events) |
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