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Model Number EL5ML |
Device Problems
Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2020 |
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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
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Event Description
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It was reported that during a kidney transplant, the device was placed on the vessel but didn't deploy a clip when fired.When removing, it tore the vessel, which was easily repaired.A similar device was used to complete the case with no patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 3/23/2020.D4: batch#: t9588g.Investigation summary: the analysis results found that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired and the clips did not advance into the jaw.The device was noted to have the tip of the advancer bent.The instrument was disassembled and upon disassembly, the advancer was confirmed to be bent and nine clips were found inside clip track.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse, could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Performed by (b)(6).
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Search Alerts/Recalls
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