Model Number NT4W18115 |
Device Problems
Break (1069); Device Fell (4014)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.If additional information becomes available following the completion of the investigation, a supplemental report will be filed.
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Event Description
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Olympus received a report from a user facility stating that during the procedure, the basket/net was detached from the instrument.The detached piece could not be retrieved and will require additional intervention for removal.No additional information has been received at this time.
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Manufacturer Narrative
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The device history records for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of (b)(4) units were produced under this lot number with no associated noncomformances (ncrs), reported scrap or recorded process deviations relating to the reported failure.
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Manufacturer Narrative
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This report is being supplemented to provide additional information regarding the reported event.The device was returned to olympus for evaluation.The device was visually inspected and the complaint was confirmed as the basket was detached at the juncture between the core wire and the basket assembly.The basket along with the corresponding connector tube used to join the assemblies were not returned to olympus.Inspection of the core wire confirmed the presence of the specified welds, under magnification these welds appeared intact.Therefore it is believed that the welding process did not contribute to the failure.As the basket was not returned, a definitive root cause could not be determined.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Complaint history review did not identify any additional complaints attributed to this lot.Complaint trending revealed the current complaint rate falls within acceptable limits, no alerts or alarms have been triggered.Olympus will continue to monitor complaints for this device through regular trending activities as defined by olympus surgical technologies america quality management system procedure.
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Manufacturer Narrative
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This report is being supplemented to provide additional information (h10) and corrected data (h10) regarding the reported event.Additional information received identified the patient underwent a second procedure and the device was successfully retrieved.Additionally, the procedure that was taking place when the reported event occurred was a ureter- ureterorenoscopy.
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Search Alerts/Recalls
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