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Model Number A22004A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report has been submitted by the importer under this mdr report number 2429304-2023-00250.H6 appropriate term: severe tear in ureter.This device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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Event Description
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A paralegal called to get the instruction for use for the oes pro resectoscope and reported to olympus that during a therapeutic left ureteroscopy and left stent placement, there was a severe tear in ureter.Attempts to obtain additional information were done, however, unsuccessful.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information inadvertently left out (d10, g2, and b5).The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.Furthermore, it was reported that no olympus scope has been involved in the reported incident.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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Event Description
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It was reported that the scope used for the reported event was not an olympus scope.
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Search Alerts/Recalls
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