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

Model Number 60-6085-202A

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-202a, vcare 200a - large, was being used during a lap hysterectomy on (b)(6) 2022 when it was reported, ¿large vcare fail.The vcare broke at handle and bent during manipulation.¿ there was no report of injury, medical intervention, or hospitalization for the patient and ¿patient is doing well¿.The procedure was completed using another large vcare device with report of no delay to the surgery.Further assessment questioning found that the vcare broke at the handle during surgery.The device did not fragment, and components did not fall into the surgical site.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the 60-6085-202a, vcare 200a - large, was being used during a lap hysterectomy on (b)(6) 2022 when it was reported, ¿large vcare fail.The vcare broke at handle and bent during manipulation.¿ there was no report of injury, medical intervention, or hospitalization for the patient and ¿patient is doing well¿.The procedure was completed using another large vcare device with report of no delay to the surgery.Further assessment questioning found that the vcare broke at the handle during surgery.The device did not fragment, and components did not fall into the surgical site.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Health effect impact code was c50912, corrected to c50675 manufacturer narrative: received one 60-6085-202a in original package.Lot number was verified.Performed a visual inspection, another package arrived for another vcare device (60-6085-202a) with no device returned.No pilot balloon was returned.Evidence confirmed the vcare broke at handle and bent during manipulation.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 was found to have met all specifications prior to shipment.A two-year lot history review was conducted and found no similar events for this lot number.A two-year review of complaint history revealed there has been a total of 62 complaints, regarding 77 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 that prior to device removal, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: VCARE 200A - LARGE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 13893164
• MDR Text Key: 288207266
• Report Number: 1320894-2022-00067
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)240110(10)202201101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: 60-6085-202A
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202201101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic