MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for V-CARE, MEDIUM (34MM) CUP 60-6085-201A manufactured by Conmed Corporation.
[184493647]
The device is not available for return or evaluation, however the provided photographic evidence exhibits the reported incident. The reported complaint of device breakage is confirmed, but root cause can not be determined. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The lot history records (lhr) were also reviewed. 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 shows this is the only complaint for this lot number and failure mode. A two-year review of complaint history for the failure mode of "balloon dislodges from stainless steel tube" pertaining to the balloon, revealed there has been a total of 26 complaints, regarding 26 devices, for this device family and failure mode. During this same time frame 496,304 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 (b)(4). A two-year review of complaint history for failure mode of "cervical cup does not stay on device" pertaining to the cups, revealed there has been a total of 22 complaints, regarding 22 devices, for this device family and failure mode. During this same time frame (b)(4). 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 (b)(4). The instructions for use (ifu) provides the user with information regarding proper care and use of this device. The ifu also advises the user to reattach the syringe to the luer connector at the end of the pilot balloon and fully aspirate the air from the intrauterine balloon to deflate; this will allow the intrauterine balloon to be removed from the uterus. Unlock the locking mechanism by turning the screw counter-clockwise and retract to the handle. Swipe finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage. Fully retract the vaginal cup to the handle. Carefully remove the device from the vagina; do not use excessive force to avoid traumatizing the vaginal canal. Upon removing vcare, the surgeon should visually inspect the vcare device and the patient to make sure the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient. (there are 5 parts/components to the vcare cervical elevator retractor. These are: 1) the balloon; 2) the forward "cervical" cup; 3) the back or vaginal cup; 4) the locking assembly with thumb screw; 5) the metal shaft and handle with balloon inflation valve. ) for safe removal of the vcare device from the patient, follow instructions. Failure to separate the vaginal cup from the tissue may result in detachment of cervical cup and/ or patient injury. Additionally, 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
[184493648]
On behalf of the customer, the conmed representative reported issues with a v-care, medium (34mm) cup, item # 60-6085-201a, lot 201912091 that occurred (b)(6) 2020 at (b)(6) hospital. It was reported the balloon fell of the end which allowed all the other parts to slide off in the patient. All the pieces were recovered from the patient. The device was discarded after the surgery. Additional information obtained indicates the robotic hysterectomy surgery was completed with no delay by using another v-care with no impact or injury to the patient. Details were provided that the issue occurred towards the end of the procedure, after being in use for approximately 90 minutes. The medical staff attempted to remove the v-care from the uterus and vaginal canal. As she pulled, only the handle, locking assembly with thumbscrew and shaft came out. The blue vaginal cup was located and removed from the tip of the vagina. The green cervical cup and detached balloon were located within the uterus and removed. The green cup had not been sutured in place, and it is believed that the balloon was still inflated when the balloon slid off the shaft followed by the green cervical and blue vaginal cups. The uterus was removed through the vaginal canal as originally planned. It is noted that the shaft did not break. The v-care green cervical cup and the balloon detached, and it appeared that they slid off the shaft. The cups were not broken apart. It was confirmed there was no injury or impact to the patient and current patient status is reported to be fine. 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 | 1320894-2020-00105 |
| MDR Report Key | 9865261 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-03-23 |
| 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 | V-CARE, MEDIUM (34MM) CUP |
| Generic Name | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-23 |
| Model Number | 60-6085-201A |
| Catalog Number | 60-6085-201A |
| Lot Number | 201912091 |
| 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 | 2020-03-23 |