Model Number URF-V3 |
Device Problem
Material Perforation (2205)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the scope was leaking from the bending section due to a puncture found in the distal end.There was also a broken pin at the bending section skeleton that had punctured through the distal end, contributing to the aforementioned leakage.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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Event Description
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The customer originally returned her olympus uretero-reno videoscope due to the unit not displaying an image during an unspecified procedure.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.During the device evaluation, it was discovered that the bending section of the device was broken and leaking.This report is being submitted to capture the broken bending section found during the device evaluation.
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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.The investigation confirmed the reported device problem.A review of the device history record found the subject device was refurbished, however the data regarding the refurbishment details is unavailable.A definitive root cause for the reported product problem was not established.However, it is probable that the issue occurred because the end user applied excessive force on the bending section; causing it to break.Design measures had previously been taken to address potential injury due to a kinked/cracked bending tube protruding during the procedure.The design of the bending tube was changed to not cause damage to the patient even if broken.As there was no reported patient injury due to the subject event, these measures are still considered effective.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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