Model Number A22002A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation (loose scope pin) was confirmed.In addition, there was a cropped image due to misalignment of the objective lens.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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Event Description
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The customer reported that when using a telescope, 30°, 4 mm, the scope pin was loose.There was no patient harm associated with the event.
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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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.
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Event Description
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The event occurred at inspection for use for a therapeutic tur-bt (transurethral resection of bladder tumor) procedure.The procedure was completed with another device without any delays.The device was inspected before use.
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Search Alerts/Recalls
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