Catalog Number 60-6085-201A |
Device Problem
Failure to Deflate (4060)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.H3 other text : device not yet received.
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Event Description
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The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a - medium was being used on (b)(6) 2023 during a hysterectomy and the ¿¿balloon did not deflate after re-testing¿.There was no impact or injury to the patient or user.The procedure was completed with an alternate unknown device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The device has not been returned to date and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.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.(b)(4).Per the instructions for use, the user is advised the following: remove the vcare from its sterile packaging and inspect for damage caused by shipping.Discard if any damage is noted.Draw 7-10 cc of air into a standard syringe and insert it into the luer connection at the end of the pilot balloon.Test the intrauterine balloon by injecting air with the syringe and checking to see if balloon remains inflated.If balloon does not remain inflated, do not use.Discard and select another vcare unit.After the successful balloon test, deflate the balloon by removing all air with the syringe.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the 60-6085-201a, vcare 200a - medium was being used on (b)(6) 2023, during a hysterectomy and the ".Balloon did not deflate after re-testing".There was no impact or injury to the patient or user.The procedure was completed with an alternate unknown device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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