Model Number MESE1 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure the device was triggering constantly.The changed rf and connect cables but the same issues continued there were no patient consequences.
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).Date sent: 2/7/2023.Serial number received: (b)(6).Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.
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Manufacturer Narrative
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Pc-(b)(4).
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Manufacturer Narrative
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(b)(4).Date sent: 3/9/2023.Investigation summary: per service manual operational and diagnostic analysis confirmed the continuous activation.The pcb assembly was replaced as identified in the investigation to address the issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The repair and testing of the unit was completed.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
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Search Alerts/Recalls
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