MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for VCARE 60-6085-200A manufactured by Conmed Corporation.
[181145389]
Elderly female with history uterine prolapse and incontinence. During procedure, robotic supracervical hysterectomy, bilateral salpingo-oophorectomy, lap sacrocolpopexy transvaginal tape sling cystoscopy, the balloon would not inflate. Instrument removed intact and another one used, no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763469 |
| MDR Report Key | 9763469 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-03 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VCARE |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-02-27 |
| Model Number | 60-6085-200A |
| Catalog Number | 60-6085-200A |
| Lot Number | 201905281 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |