MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for VCARE 60-6085-202A manufactured by Conmed Corporation.
[178335645]
During use for robotic assisted hysterectomy and bilateral salpingectomy, md inserted device into patient's vaginal cavity, inflated balloon and it was discovered balloon would not stay inflated. Device was removed and inspected and could not identify why balloon would not stay inflated. Item changed out and replaced with same type without any issues. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9686479 |
| MDR Report Key | 9686479 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-24 |
| Report Date | 2020-01-02 |
| Date Reported to FDA | 2020-01-02 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Model Number | 60-6085-202A |
| Catalog Number | 60-6085-202A |
| Lot Number | 201901211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| 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 | 2020-02-10 |