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Model Number EL5ML |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being 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.
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Event Description
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It was reported that during an unknown procedure, device was not clipping properly, it didn¿t close the clips properly.There was no delay to procedure and no patient consequence was reported.
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Manufacturer Narrative
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(b)(4).D4: batch # t94r7e.Investigation summary : the analysis results found that the el5ml device was returned with no damage in the external components.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.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.
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Search Alerts/Recalls
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