ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10370)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10370) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: MONOPOLAR CURVED SCISSORS; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | MONOPOLAR CURVED SCISSORS |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10370 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS DISASSEMBLED AND THE CONDUCTOR WIRE WAS FOUND TO BE BROKEN AT THE PROXIMAL END OF THE MAIN TUBE. THE WIRE WAS LIKELY PINCHED BETWEEN THE MAIN TUBE AND OUTPUT ROLL GEAR WHICH, OVER TIME |
| Source | openFDA MAUDE (device adverse events) |
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