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

Catalog Number	60-6085-202A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The customer reported that the 60-6085-202a, vcare 200a ¿ large was being used during a hysterectomy total vaginal robot assisted procedure on (b)(6) 2023 and the ¿the white handle came off the device.There were no injuries to patient or staff.¿.Per further assessment it was found, the device was in the uterus at the time the handle came off and all pieces were removed from the patient.The procedure was completed with ¿another device¿ and there was no delay.There was no impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the 60-6085-202a, vcare 200a ¿ large was being used during a hysterectomy total vaginal robot assisted procedure on (b)(6) 2023 and the "the white handle came off the device.There were no injuries to patient or staff." per further assessment it was found, the device was in the uterus at the time the handle came off and all pieces were removed from the patient.The procedure was completed with "another device" and there was no delay.There was no impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-6085-202a in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection per ifu, the complaint was confirmed.The handle spun due to a break of the inside components.Root cause cannot be determined; however, a possible cause of this event could be a result of torsional and axial loading.Although there was a presence of shrinkage stresses present, this is inherent to the molding process.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: 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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: VCARE 200A - LARGE
• Common Device Name: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18147284
• Report Number: 1320894-2023-00251
• Device Sequence Number: 17861339
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)241016(10)202210171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2024
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202210171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic