MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for VCARE, LARGE (37MM) CUP 60-6085-202A manufactured by Conmed Corporation.
[187570740]
Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received. At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[187570741]
The customer reported issues with the vcare, large (37mm) cup, item # 60-6085-202a, lot # 201910211 that occurred (b)(6) 2020 at (b)(6) medical center. It was reported that during a robotic hysterectomy on (b)(6) 2020, the v-care tip fell apart during removal. The balloon fell off and the cervical cup came off in the patient. It is noted that the detached parts were removed from the patient, there was no impact or injury to the patient and the procedure was successfully completed with no delay, using an allis clamp. To date, although multiple attempts have been made to gather additional information, no clarification or information has been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00151 |
| MDR Report Key | 9903131 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995557 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VCARE, LARGE (37MM) CUP |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-31 |
| Catalog Number | 60-6085-202A |
| Lot Number | 201910211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |