ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10361)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10361) 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 | 2955842-2020-10361 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IMAGE/VIDEO REVIEW NOT POSSIBLE AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONFIRMED THE CUSTOMER REP |
| Source | openFDA MAUDE (device adverse events) |
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