Model Number 209012 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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No further information is available on the product at this time.The investigation is ongoing; however, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
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Event Description
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Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint #(b)(4).
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Manufacturer Narrative
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Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The actual device was determined to be available for evaluation.The end user indicated that the eye of the needle broke off during the suturing of a chest tube.The wound was explored by the surgeon.The eye of the needle was not located.No further patient follow-up.The broken needle sample was returned.Upon review of the broken needle, it was noted that marks were identified close to the eye and point of the needle.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.A review of the samples returned show that the needles were clamped improperly either not on the flat side or too close to the eye or point, which likely caused them to break.Based on this information, the root cause is attributed to customer misuse and no further action is required.
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Event Description
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Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint # (b)(4).
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Search Alerts/Recalls
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