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Model Number EL5ML |
Device Problems
Mechanical Problem (1384); Firing Problem (4011)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.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 during a laparoscopic cholecystectomy, there was an unusual feeling when grasping the trigger.The device was replaced, but the issue did not improve, and the jaws were misaligned.The device was used on the blood vessels.Another device was used to complete the case.There were no adverse consequences to the patient.
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Manufacturer Narrative
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Pc-(b)(4).Batch # x94p6t.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 1 conforming clip.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.In order to evaluate the condition of the internal components, the device was disassembled, and no anomalies could be observed.The event described could not be confirmed as the device performed without any difficulties noted.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.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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