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 2020-03-26 for VCARE, MEDIUM (34MM) CUP 60-6085-201A manufactured by Conmed Corporation.
[188662447]
The device in question has been received by conmed and has entered into the evaluation process. 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
[188662448]
On behalf of the customer, the conmed representative reported issues with the vcare, medium (34mm) cup, item 60-6085-201a, lot 201912021 that were experienced by dr. (b)(6) on (b)(6) 2020 at (b)(6) university medicine pavilion. It was reported the cervical cup and occluder came off the manipulator inside the patient. It is noted that there was no impact or injury to the patient and the procedure was successfully completed with a delay, unknown length. Additional information indicates the laparoscopic hysterectomy was completed with a delay in the case to retrieve the cup and occluder. The physician was attempting to remove the uterus through the vagina attached to the v-care, barely pulled and the v-care shaft came out. She was removing the vcare from the vagina after the colpotomy was performed and the entire shaft came free without cups. The green cervical and blue vaginal cup came completely off the handle. The issue occurred at the end of procedure, after being in use for approximately 90 minutes. After all pieces were removed by the physician by hand, the uterus was removed though the vagina. The green cup had not been sutured in place, and it is believed that the balloon was still inflated when the balloon detached. It is noted that the shaft did not break. The cups were not broken apart. No other information was provided. 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 | 1320894-2020-00096 |
| MDR Report Key | 9882728 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-12-02 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | 60-6085-201A |
| Lot Number | 201912021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-26 |