Model Number 35BX |
Device Problems
Break (1069); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that during a diagnostic percutaneous nepro lithotripsy procedure two different sure glidewire wire tips broke inside the patient.The user repositioned the patient to lithotomy and both of the tips were removed and retrieved successfully using grasper.The intended procedure was completed with no known patient harm or injury reported.No patient or user injury was reported.This report is related to report patient identifier (b)(6).
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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 investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device return evaluation confirmed the tip breakage and no other damages were found on the device.The device was sent to the oem (original equipment manufacturer) where they conducted their own investigation.The oem was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, a definitive root cause cannot be conclusively determined for the reported phenomenon.Based on the information provided and investigation, probable cause of the reported issue could be due to use and or handling issue.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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