The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: bending section cover stretched and adhesive crack, image guide breakage, insulation failed, and biopsy port missing.The investigation is ongoing.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: bending section cover stretched and adhesive crack, image guide breakage, insulation failed, and biopsy port missing.The investigation is ongoing.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.
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