ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10346)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10346) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: SMALL GRASPING RETRACTOR; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | SMALL GRASPING RETRACTOR |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10346 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SMALL GRASPING RETRACTOR ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS 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 SITE HISTORY REVI |
| Source | openFDA MAUDE (device adverse events) |
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