MAUDE Adverse Event Report: CONMED CORPORATION V-CARE, MEDIUM (34MM) CUP; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-201A

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.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 0.00005.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 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 0.00004.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.

Event Description

On behalf of the customer, the conmed representative reported issues with a v-care, medium (34mm) cup, item 60-6085-201a, unknown lot that occurred at (b)(6) hospital.Event date unknown.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 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 on the v-care to remove it, only the handle, locking assembly with thumbscrew and shaft came out.The blue vaginal cup was located at the tip of the vagina and removed.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 cups were not broken apart.It was confirmed current patient status is fine.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.

Event Description

Additional information was received by conmed by way of fda medwatch medsun mandatory and voluntary report form 3500a # (b)(4).Clarification received indicates issue occurred during a robot assisted laparoscopic vaginal hysterectomy sometime in (b)(6) 2020.Lot number 201912091 was also provided.No other additional information was provided.

Manufacturer Narrative

Additional information was received by conmed on 03april2020 by way of fda medwatch medsun mandatory and voluntary report form 3500a # (b)(4).B3: date of event was provided as (b)(6) 2020 only.H10 : the investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record and lot 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 a total of 2 complaints involving 2 devices for this lot number and failure mode for both the balloon and cup detachment.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.(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.(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.All other information previously submitted remains unchanged.

• Brand Name: V-CARE, MEDIUM (34MM) CUP
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica, ny
• MDR Report Key: 9865303
• MDR Text Key: 187565289
• Report Number: 1320894-2020-00106
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201912091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1