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Catalog Number EL5ML |
Device Problems
Mechanical Problem (1384); Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 12/15/2023 d4: batch # a9de60 a manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.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 during an unknown procedure, the tip of the clip was broken, and could not be clipped.The issue continuously occurred.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4).Date sent: 1/9/2024.D4: batch # a9de60.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 6 conforming clips. upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended. although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torquing may result in clip malformation.Do not insert the clip applier through a trocar if a clip is present in the jaws.This may result in clip malformation, dislodged clips, or damage to the instrument.If a clip is present in the jaws, fully squeeze the trigger against the handle, then fully release the trigger to release the clip from the jaws before inserting the device through the trocar.The event described could not be confirmed as the device performed without any difficulties noted.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 batch and lot number, and no non-conformances were identified.
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Search Alerts/Recalls
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