ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10386)
ENDOWRIST Adverse Event — Malfunction (MDR 2955842-2020-10386) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOWRIST; Generic name: PERMANENT CAUTERY HOOK; Manufacturer: INTUITIVE SURGICAL, INC.
| Device | ENDOWRIST |
|---|---|
| Generic name | PERMANENT CAUTERY HOOK |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Report number | 2955842-2020-10386 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY AND DISTAL CLEVIS. BLACK CHAR MARKS WERE PRESENT THE DISTAL END. ANY MATERIAL MISSING FROM THE DAMAGE OF THE YAW PULLEY WAS LIKELY T |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →