An end user reported an issue with an evlt kit, with spotlight ops sheath 25cm.During preparation, the fiber was removed from the packaging and the tip was discovered to be bent/cracked.There was no visible damage to the internal or external packaging.The following procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.
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As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of fiber shaft fractured near tip was not confirmed since no sample was received for evaluation. without receiving a fiber sample for evaluation a definitive root cause cannot be determined.Potential root cause is handling damage to fiber during transit and/or receiving at customer facility.At the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed. the review confirmed that the packaging lots met all material, assembly, and performance specification.Labeling review: the directions for use which is supplied to the end user with this catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends reference (b)(4).
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