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 2020-01-13 for V-CARE MEDIUM CUP (34MM) 60-6085-201A manufactured by Conmed Corporation.
[181401022]
Received one 60-6085-201a opened original packaging. Lot number could not be verified. Performed a visual inspection, the device was fully disassembled. There is evidence of adhesion where the balloon attaches to the shaft. Excessive force could be a possible cause. A 2 year lot history review could not be conducted as a lot number was not provided. A dhr review could not be conducted as a lot number was not provided. A two-year review of complaint history revealed there has been 32 complaints regarding 67 devices for this device family and failure mode. During the same time frame 631,168 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be. 0001. Per the instructions for use, the user is advised the following; to carefully remove the device from the vagina; do not use excessive force to avoid traumatizing the vaginal canal and/ or component detachment. Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[181401023]
The conmed representative reported on behalf of the customer that the 60-6085-201a, v-care medium, broke inside the patient during the procedure. There is no reported injury or impact to the patient. Additional information was received that stated; the device broke completely during a total hysterectomy on (b)(6) 2019. Based on the picture provided by the conmed representative and a conference call on (b)(6) 2020 the balloon tip completely detached allowing the cups to fall off approximately mid-procedure. The procedure was completed using another v-care with no issues. The surgical team is very experienced using this product. This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00439 |
| MDR Report Key | 9580839 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-13 |
| 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 | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-CARE MEDIUM CUP (34MM) |
| Generic Name | UTERINE MANIPULATOR |
| Product Code | LKF |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2019-12-20 |
| Catalog Number | 60-6085-201A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |