ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10347)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10347) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: TENACULUM FORCEPS; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | TENACULUM FORCEPS |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10347 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. A REVIEW OF THE INSTRUMENT LOG FOR THE TENACULU |
| Source | openFDA MAUDE (device adverse events) |
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