MAUDE Adverse Event Report: CONMED CORPORATION V-CARE SMALL (32MM) CUP; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-200A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported issues with v-care small (32mm) cup, item 60-6085-200a, that occurred at (b)(6).This record captures general issues that were mentioned while reporting another incident (captured in (b)(4) / 1320894-2020-00578).It was reported that the facility had "multiple issues with the vcare.Early this past month, they had three separate vcare with the handles breaking off".There were no specific event dates or lots reported for these incidents.There was no indication of patient impact, however it was noted the procedures were completed.To date, although multiple attempts have been made to gather additional information, no clarification has been made available.Since the handle of the vcare would be in very close proximity to the vaginal opening, if broken off while the vcare was in place, this would pose possible risk to the patient.Although there is limited information on this reported issue, these incidents will be reported on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device has not been returned to conmed for evaluation and its location is unknown.No photographic evidence has been provided.Therefore, the reported breakage failure cannot be verified, and root cause can not be identified.Should the device be returned an evaluation will be performed and upon completion of the complaint investigation a supplemental and final report will be filed.As a lot number was not provided, conmed could not conduct a review of the manufacturing documents from the device history record (dhr).The two-year lot history could not be reviewed for this same reason.A two-year review of complaint history revealed there has been a total of (b)(4)complaints, regarding (b)(4) 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 0.00002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu it also gives direction as to removing the vcare after use, including but not limited to 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: V-CARE SMALL (32MM) CUP
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11108517
• MDR Text Key: 225360776
• Report Number: 1320894-2020-00579
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/18/2021
• Patient Sequence Number: 1