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Model Number EL5ML |
Device Problems
Failure to Form Staple (2579); Failure to Fire (2610); No Apparent Adverse Event (3189)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 06/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: (b)(4) 2022.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide more details, what was the amount of the blood loss (mls)? was a transfusion required? was the procedure altered as a result of the event? were there any patient consequences? if yes, please describe.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 inguinal hernia repair when using the clip applier, on the first attempt to pass the 5mm trocar, one of the clips automatically armed, which forced the clip to be removed from the abdominal cavity.A new test of the clipper was performed outside the patient and it was functioning.Pass the automatic clipper through the trocar again, carefully, so that there is no new failure with the armed clip.When applying and closing the clip to use the clip in testicular vascularization, it sectioned the patient's testicular vessel, without offering the clip for local ligation.Hemostasis was performed with an electric scalpel.
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Manufacturer Narrative
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(b)(4) date sent: 10/19/2022 d4: batch # u9601a 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 9 conforming clips.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.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-conformance were identified.
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Search Alerts/Recalls
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