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Customer complaint stated "suction failure was observed," and japan qa comment stated "the poor suction was due to a broken tube" and "the tube near the slide was cut by 2mm"; no serious injury was identified, medical intervention required, or follow-up care needed, and the procedure was able to be completed.Photographs were provided by the complainant and were reviewed as part of the investigation, the complaint was forwarded to the vendor for further evaluation, and the vendor reported that batch records and retain samples from the same batch were reviewed.The reported damage condition was confirmed, and the vendor further reported that no abnormalities were identified.The cause was documented as "comp./part defective, broke," and the damage condition was characterized as an isolated occurrence affecting an individual unit.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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