MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	60-6085-202A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: VCARE
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 17331927
• Report Number: 17331927
• Device Sequence Number: 12595446
• Product Code: LKF
• UDI-Device Identifier: 10653405003809
• UDI-Public: (01)10653405003809(17)240117(10)202201171
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/02/2023
• Report Date (Section F): 05/02/2023

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 Model Number: 60-6085-202A
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 202201171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 05/02/2023