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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 09/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 sigmoidectomy, a breaking sound was heard, and the clip was not formed fully when the trigger was grasped.It occurred several times.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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