It was reported that during an unknown procedure, the firstpass was breaking up.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h6: the device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2040221 found no non-conformances or anomalies during manufacturing process related to the reported event.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.(2) tissue thickness.No containment or corrective actions are recommended at this time.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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