OLYMPUS WINTER & IBE GMBH WORKING INSERT, ALBARRAN, TWO WAY; WORKING INSERTS WITH ALBARAN LEVER
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Model Number A20972A |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 06/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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Event Description
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Olympus was informed that during a therapeutic ureteral stent placement procedure, the raising wire at the distal end of the device got bent and could no longer be returned to 0 degrees.When removing the device for replacement, the patient¿s ureter was injured and bleeding occurred.However, the intended procedure was completed using a similar device but the patient¿s hospitalization was prolonged due to the injury.
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the pull wires of the albarran lever are severely bent.Consequently, the function of the albarran is no longer provided.This damage was most likely caused by external force or improper handling during preparation for use or reprocessing.Thus, this event/incident was attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the working insert without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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