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 2020-01-21 for V-CARE, LARGE, 37MM CUP 60-6085-202A manufactured by Conmed Corporation.
[181401609]
The device is not being returned but photographic evidence was provided and confirmed the reported problem of the shaft breakage. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue. A two-year lot history review was conducted and found this is the only complaint for this lot number and failure mode. A two-year review of complaint history for failure mode of "cracked or broken" revealed there has been a total of 20 complaints, regarding 26 devices, for this device family and failure mode. During this same time frame 631,336 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0. 00004. The instructions for use (ifu) provides the user with information regarding proper care and use of this device. Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected. The ifu advises the user that if bending vcare is necessary for use with robotic instruments, then all device systems must be tested before use to ensure functionality. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[181401610]
On behalf of the customer, the conmed rep reported issues with the v-care, large, 37mm cup, item 60-6085-202a, lot # 201907291 that occurred on (b)(6) 2019 at (b)(6) healthcare in (b)(6). It was reported that "during the case, very large patient, had to do a lot of manipulating of the uterus, due to the wear and tear, handle broke". Additional information obtained indicates the issue occurred (b)(6) 2019 during a robotic hysterectomy being performed on a "very large" patient. The v-care had been in place for about 2 hours prior to the handle breaking during the colpotomy. The issue occurred when the pa was manipulating the uterus. It was reported that there was a lot of movement and manipulating of the uterus and v-care device. After some time, the pa realized that she couldn't really move the uterus where the surgeon wanted so she looked down and saw that the handle had come apart from the manipulator shaft itself and was hanging by the inner tubing. The pa then got forceps and used that to hold onto the manipulator shaft and used the forceps as her handle. The breakage occurred while the v-care was still in place within the uterus. The cervical cup was not sutured in place, but the thumb screw was tightened. The uterus was being removed through the vaginal canal by using the v-care, then after the colpotomy removing the uterus with forceps. The procedure was successfully completed robotically with no reported delay. The incident did not extend the patient's stay or length of procedure and she suffered no adverse effects and is recovering normally at home. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence for the breakage of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00451 |
| MDR Report Key | 9610994 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-07-29 |
| Date Added to Maude | 2020-01-21 |
| 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 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734908 |
| Manufacturer Phone | 7273995557 |
| 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, LARGE, 37MM CUP |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-01-21 |
| Catalog Number | 60-6085-202A |
| Lot Number | 201907291 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-21 |