MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-05 for VCARE, MEDIUM (34MM) CUP 60-6085-201A manufactured by Conmed Corporation.
[183315036]
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
[183315037]
On behalf of the customer, the conmed representative reported issues with a vcare, medium (34mm) cup, item # 60-6085-201a, lot # 201908191 that occurred (b)(6) 2020 at henry ford allegiance health. It was reported that during the end of the procedure as the physician was withdrawing the uterine manipulator the balloon came off the tip of the device causing green cup to also fall off. All items were accounted for. It is noted that there was no impact or injury to the patient and the procedure was successfully completed with no reported delay. Additional information obtained indicates that the issue occurred during a robot-assisted vaginal hysterectomy and bilateral salpingo-oophorectomy. It was reported that before removal of the uterus, the manipulator was withdrawn and found to be in pieces. All pieces came out with manipulator; final piece fell out onto floor. It was confirmed that only the balloon and cervical cup slid off the shaft. The vcare device had been used throughout procedure without known issue and was not replaced after removal. The uterus was successfully removed vaginally using forceps as planned. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as no fragments were left.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00085 |
| MDR Report Key | 9792389 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-05 |
| 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, MEDIUM (34MM) CUP |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-05 |
| Catalog Number | 60-6085-201A |
| Lot Number | 201908191 |
| 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 | 2020-03-05 |