The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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It was reported that a ureteral stent was placed on the patient during a percutaneous renal lithotripsy surgery.The stent was left in place for about a month and there was a stone formation concentrated at the middle of the stent and there was no floor plan.The bracket was replaced.Per follow up information received via ibc on 25apr2024, the stent was directly extubated and removed, but this time it was not serious enough to be removed after using holmium laser lithotripsy.
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