MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for VCARE 606085202A manufactured by Conmed Corporation.
[178126219]
V-care large uterine manipulator opened didn't work and didn't stay open for surgeon. Device not working properly with balloon inflated. No pt harm and no delay in the procedure. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092782 |
| MDR Report Key | 9676567 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-12-20 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VCARE |
| Generic Name | CANNULA, MANIPULATOR / INJECTOR |
| Product Code | LKF |
| Date Received | 2020-02-05 |
| Model Number | 606085202A |
| Lot Number | 201909161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Product Code | --- |
| Date Received | 2020-02-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |