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Model Number NT4F19115 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2023 |
Event Type
Injury
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Event Description
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The customer reported to olympus the flex-catch 4 wire nitinol basket was being used during a ureteroscopy with laser lithotripsy when the doctor noticed the targeted stone was too large for this basket.The doctor could not get the basket to release or dislodge from the ureter.A holmium laser was used to cut and release the basket prongs and graspers were used to gather the pieces.After doing so, another basket was retrieved and used to complete the procedure.The procedure ran over the scheduled time by 93 minutes, but it was not indicated whether this delay was a result of the additional measures being taken to remove the basket.There were no reports of patient harm as a result of the basket not releasing.
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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 device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the stone was too large.Per the instructions for use (ifu), the stone retrieval device should not have been used if the stone is too large.The event can be detected/prevented by following the ifu which state: "prior to the procedure, determine the size of the stone using imaging techniques to avoid stone sticking.Do not use the stone retrieval devices if the stone is too large.It is recommended to dilate the ureter before endoscopy and stone removal to prevent sticking during retraction." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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