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

Model Number 60-6085-201A

Device Problem Unintended Movement (3026)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a - medium, was used during a hysterectomy procedure on (b)(6) 2022 when it was reported, ¿handle came loose during check before use.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate device without any delay being reported.Further assessment questioning found that the handle of the device spins in a 360-degree motion.There was no fragmentation of the device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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, vcare 200a - medium, was used during a hysterectomy procedure on (b)(6) 2022 when it was reported, ¿handle came loose during check before use.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate device without any delay being reported.Further assessment questioning found that the handle of the device spins in a 360-degree motion.There was no fragmentation of the device.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.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.There are 3 complaints for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 60 complaints, regarding 71 devices, for this device family and failure mode.During this same time frame(b)(4) 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.(figure #4) do not use excessive force upon device removal to avoid traumatizing the vaginal canal and /or component detachment.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Correction: h6, type of investigation, removed 4114 and added 10.H6, investigation findings, removed 3221 and added 3252.Added evaluation of the device.Manufacturing narrative: received one 60-6085-201a in original package.Lot number was verified.Performed a visual inspection, evidence of device being used was confirmed.Performed a functional test by dissembling the device, the device was broken within the handle which caused the spinning 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.There are 3 complaints for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 60 complaints, regarding 71 devices, for this device family and failure mode.During this same time frame (b)(4) 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.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, vcare 200a - medium, was used during a hysterectomy procedure on (b)(6) 2022 when it was reported, ¿handle came loose during check before use.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate device without any delay being reported.Further assessment questioning found that the handle of the device spins in a 360-degree motion.There was no fragmentation of the device.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
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13823675
• MDR Text Key: 287578032
• Report Number: 1320894-2022-00063
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)230426(10)202104261
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202104261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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 Ethnicity: Non Hispanic