MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for VCARE MEDIUM 60-6085-201 manufactured by Conmed Corporation.
[185501431]
Upon removing the conmed medium v-care uterine manipulating retractor from the vagina, it fell apart. It is not meant to disassemble. The cervix with uterus attached was secured to the green size 34mm cervical cup of the v-care as per procedure/ surgical norm. This green cup fell apart from the blue obturator/ manipulator. Device was removed from service and all pieces were obtained. The specimen was also removed successfully with no harm to the patient and no delay in procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896971 |
| MDR Report Key | 9896971 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-13 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 MEDIUM |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-30 |
| Model Number | 60-6085-201 |
| Catalog Number | 60-6085-201 |
| Lot Number | 201911250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 0 YR |
| 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 | 2020-03-30 |