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	Foreign Body In Patient (2687)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint was created due to the receipt of a medsun report (b)(4) received on 17jul23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-202a, vcare 200a ¿ large.The report states that on 6apr21 there was a ¿retained foreign body.The patient represented to the office after having a ct that demonstrated retained cup of vaginal manipulator that was used at the time of her supracervical hysterectomy and underwent exam under anesthesia and removal of foreign object this morning.It's apparent that the uterine manipulator had been broken at some point during the initial case and the lower part of the cup and the balloon were left inside.This has happened at another hospital within our system.¿.After further assessment it was found, the 2nd surgery to retrieve the device fragment took place on 3nov22.Clarification of ¿this happened at another hospital within our system¿ revealed there was no 2nd incident involving a vcare, "no incident it was stated that we use this system at other facilities within our hospital system.".It is unknown if there was prolonged hospitalization for the patient.This report is being raised due to the reported injury of a second surgery was required to retrieve device fragments.
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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.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: the cervical/vaginal cup locking mechanism must be locked at all times when using vcare for uterine manipulation.If lock inadvertently becomes open, secure it immediately before proceeding.Unlock the locking mechanism by turning the thumbscrew counter-clockwise (anti-clockwise) and retract to the handle.A.Swipe a finger around the edge of the vaginal cup to separate the 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.Upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medsun report (b)(4) received on 17jul23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 60-6085-202a, vcare 200a ¿ large.The report states that on 6apr21 there was a ¿retained foreign body.The patient represented to the office after having a ct that demonstrated retained cup of vaginal manipulator that was used at the time of her supracervical hysterectomy and underwent exam under anesthesia and removal of foreign object this morning.It's apparent that the uterine manipulator had been broken at some point during the initial case and the lower part of the cup and the balloon were left inside.This has happened at another hospital within our system.¿.After further assessment it was found, the 2nd surgery to retrieve the device fragment took place on (b)(6) 2022.Clarification of ¿this happened at another hospital within our system¿ revealed there was no 2nd incident involving a vcare, "no incident it was stated that we use this system at other facilities within our hospital system.".It is unknown if there was prolonged hospitalization for the patient.This report is being raised due to the reported injury of a second surgery was required to retrieve device fragments.

• 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: 17446241
• Report Number: 1320894-2023-00151
• Device Sequence Number: 11441052
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)240117(10)202201171
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2024
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202201171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic