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Model Number EL5ML |
Device Problems
Failure to Form Staple (2579); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # u93z8f.Investigation summary: the analysis results found 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 clips.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
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Event Description
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It was reported that during a laparoscopic sigmoidectomy, an unexpected sound was heard every time the trigger was grasped although the device did not clamp a foreign matter, or the blood vessel was not hard.The clip was unformed and misaligned.The device was used on the blood vessel.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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Search Alerts/Recalls
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