ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10349)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10349) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: LARGE SUTURE CUT NEEDLE DRIVER; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | LARGE SUTURE CUT NEEDLE DRIVER |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10349 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE LARGE SUTURECUT NEEDLE DRIVER ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF A BROKEN CABLE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN T |
| Source | openFDA MAUDE (device adverse events) |
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