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Catalog Number 778626 |
Device Problem
Calcified (1077)
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Patient Problems
Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that on (b)(6) 2023, the patient underwent surgical treatment and the ureteral stent was removed.During the process, it was found that calculus formed on the wall of part of the ureteral stent, the segment in the bladder, which was difficult to remove.It was stated that the patient's pain and discomfort increased during the operation.No medical intervention was reported.Per additional information via email from ibc on 07jul2023, it was stated that the stone volume was large, the stent removal was difficult, and the pain and discomfort of patients were increased.Additional medical measures were taken, and the stent was removed with the soft mirror crushing the stone.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for investigations.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review is not required as no lot number was reported for this investigation.The instructions for use were found adequate and state the following: "ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days." "the stent is not intended as a permanent indwelling device." 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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Event Description
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It was reported that on (b)(6) 2023, the patient underwent surgical treatment and the ureteral stent was removed.During the process, it was found that calculus formed on the wall of part of the ureteral stent, the segment in the bladder, which was difficult to remove.It was stated that the patient's pain and discomfort increased during the operation.Per additional information via email from ibc on 07jul2023, it was stated that the stone volume was large, the stent removal was difficult, and the pain and discomfort of patients were increased.Additional medical measures were taken, and the stent was removed with the soft mirror crushing the stone.
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Search Alerts/Recalls
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