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Model Number EL5ML |
Device Problems
Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # u94m52.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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Event Description
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It was reported that the device was defective in the packaging.The device had a bent tip.Device was not used during an actual procedure.No patient consequence.
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Manufacturer Narrative
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(b)(4).Date sent: 3/14/2023.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was received sealed inside its original packaging with the shaft bent.Upon visual inspection, it was observed that the blister from the packaging was damaged but not perforated.The device was removed from the sterile barrier to visually inspect the jaws and no anomalies could be observed.Although no conclusion could be reach on the cause of the reported event as per conditions of the returned device.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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