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Catalog Number LX107 |
Device Problems
Unintended Ejection (1234); Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure, the clips are not clipping properly and are not effective.No patient harm.
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Manufacturer Narrative
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(b)(4).Date sent: 4/11/2024.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.Additional information was requested and the following was obtained: "how did device not work? some fell out , some scissored.Did device jammed (not fire clips)? jamming wasn¿t a problem, clips fell ou.T did device not feed clips? manual.Did device drop or eject clips? yes.Did device sideways feed clips? no.Did device fire malformed clips? yes.Did device fire scissored clips? yes".An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.
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Search Alerts/Recalls
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