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

Catalog Number 60-6085-201A

Device Problem Fracture (1260)

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

Event Date 06/07/2021

Event Type  malfunction  

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.

Event Description

The customer reported that the device, 60-6085-201a, was being used during a hysterectomy on (b)(6) 2021 when it was reported ¿a medsun report has been submitted in regards to a vcare medium uterine manipulator used at vcu health system: when removing the uterus through the vagina the balloon tip broke off in the patient.No patient harm.The device is available for return and evaluation.¿ a copy of the medsun report was not available when requested from reporter.The reporter stated that the report number was (b)(4).The device components were retrieved from the patient and the procedure was completed.There was no report of injury, medical intervention, or hospitalization for the patient.The patient was reported as having been discharged after the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The customer reported that the device, 60-6085-201a, was being used during a hysterectomy on (b)(6) 2021 when it was reported ¿a medsun report has been submitted in regards to a vcare medium uterine manipulator used at vcu health system: when removing the uterus through the vagina the balloon tip broke off in the patient.No patient harm.The device is available for return and evaluation.¿ a copy of the medsun report was not available when requested from reporter.The reporter stated that the report number was 2021-8027.The device components were retrieved from the patient and the procedure was completed.There was no report of injury, medical intervention, or hospitalization for the patient.The patient was reported as having been discharged after the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Additional information for g2: medwatch (b)(4) has been received as of 13jul21.All additional information from the medwatch has been updated in this report.The device will not be returned for evaluation and no photographic evidence has been provided, therefore, the reported failure 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: re-attach the syringe to the luer connector at the end of the pilot balloon; fully aspirate the air from the intrauterine balloon to deflate.B) fully retract the vaginal cup to the handle.Carefully remove the device form the vagina.Do not use excessive force upon device removal to avoid traumatizing the vaginal canal.Upon removing the vcare, the surgeon should visually inspect the vcare device and the patient to ensure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.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
• MDR Report Key: 12017817
• MDR Text Key: 260995682
• Report Number: 1320894-2021-00302
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 202104191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 71