MAUDE Adverse Event Report: CONMED UTICA VCARE 200A - MEDIUM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-201A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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

The sales representative reported on behalf of the customer that the 60-6085-201a was being used during a robotic lap total hysterectomy on an unknown date when it was reported ¿reported today june 9th by (b)(6) the scrub tech told me today that a few weeks ago the plastic white piece under the balloon was found inside the patient.He indicated the vcare did not stay together and fell apart inside patient when the colpotomy was complete.This was confirmed by the (nurse) because she went through the pieces on the back table to make sure everything was recovered including the balloon, white piece and both cups.The product was pitched after the case.¿.The procedure was completed without the use of an alternate device and there was no delay reported.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.A device history record review cannot not be conducted as no lot number was provided.A lot history review cannot be conducted as no lot number was provided.A two-year review of complaint history revealed there has been a total of 115 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 (b)(4).Per the instructions for use, the user is advised to re-attach the syringe to the luer connector at the end of the pilot balloon; 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 thumbscrew counter-clockwise (anti-clockwise) and retract to the handle.A) swipe finger around the edge of the vaginal cup to separate tissue from the cup to prevent tissue damage.B) 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a was being used during a robotic lap total hysterectomy on an unknown date when it was reported ¿reported today june 9th by matt the scrub tech told me today that a few weeks ago the plastic white piece under the balloon was found inside the patient.He indicated the vcare did not stay together and fell apart inside patient when the colpotomy was complete.This was confirmed by the (nurse) because she went through the pieces on the back table to make sure everything was recovered including the balloon, white piece and both cups.The product was pitched after the case.¿.The procedure was completed without the use of an alternate device and there was no delay reported.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: VCARE 200A - MEDIUM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12028337
• MDR Text Key: 257549138
• Report Number: 1320894-2021-00305
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Patient Sequence Number: 1