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

Catalog Number 60-6085-201A

Device Problem Unintended Movement (3026)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

The sale representative reported that the device, 60-6085-201a, vcare 200a medium, was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported that "the handle was not fixed and turned after the star of surgery.¿ follow up assessment questioning found that "a fragment or component did not fall into the surgical site." there was no delay reported, and the procedure was completed using alternate device.The patient was not injured, there was no medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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 sale representative reported that the device,60-6085-201a, vcare 200a - medium, was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported that "the handle was not fixed and turned after the star of surgery.¿ follow up assessment questioning found that "a fragment or component did not fall into the surgical site." there was no delay reported, and the procedure was completed using alternate device.The patient was not injured, there was no medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Visual examination of the returned, used device found that the handle rotates 360 degrees.The damaged condition of the returned used device is indicative that inside the handle is broken.A two-year review of complaint history revealed there has been a total of 69 complaints, regarding 87 devices, for this device family and failure mode.(b)(4).Ifu 17698 e, advises the user 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.

• 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: samantha dewberry ; 525 french rd; utica, NY 13502 ; 3152230184
• MDR Report Key: 14657169
• MDR Text Key: 293922302
• Report Number: 1320894-2022-00125
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic