VCARE Adverse Event — Malfunction (MDR 10004528)
VCARE Adverse Event — Malfunction (MDR 10004528) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VCARE; Generic name: CANNULA, MANIPULATOR/INJECTOR, UTERINE; Manufacturer: CONMED CORPORATION.
| Device | VCARE |
|---|---|
| Generic name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Manufacturer | CONMED CORPORATION |
| Report number | 10004528 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, DOCTOR WENT TO PULL OUT THE V-CARE UTERINE MANIPULATOR WITH THE DETACHED UTERUS ATTACHED. WHEN SHE PULLED THE V-CARE TO REMOVE IT, THE V-CARE BROKE APART INTO THREE PIECES. SHE WAS HOLDING THE HAND PIECE BUT THE CUP THAT HOLDS THE CERVIX/UTERUS DID NOT COME OUT WITH THE UTERUS ATTACHED AS ANTICIPATED. UPON FURTHER INSPECTION THROUGH THE LAPAROSC |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →