BOSTON SCIENTIFIC CORPORATION LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Tract Infection (2120)
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Event Date 04/01/2022 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a lithovue elite flexscope was used during a ureteroscopy procedure performed on an unknown date.Per the article, a single-arm retrospective observational analysis was performed in 50 consecutive patients undergoing ureteroscopic lithotripsy using the lithovue elite system, with pressure sensing capability between april 2022 to february 2023 at two centres.A pressure bag set at 150mmhg or hand irrigation with a 60cc syringe was used for irrigation and a ureteral access sheath was places at the physician discretion.Median and maximum intrarenal pressure, and relative cumulative time exceeding 20, 40, 60, 80, 100, 120, 140 and 200mmhg per total procedure time were analyzed.Reportedly, one of the patients presented to emergency department with signs and symptoms of lower urinary tract infection and treated with antibiotics as an outpatient.
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Manufacturer Narrative
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Exact date unknown, event occurred from april 2022 to february 2023.: the suspected device upn and lot number could not be provided.The exact device expiration date is unknown; however, it was reported that the device was not expired.Block g2: literature source chew, b.H., bhojani, n., koo, k.C., bensaadi, k., halawani, a., & wong, v.Kf.(2023).Retrospective first-in-human use of the lithovue elite ureteroscope to measure intrarenal pressure.Wiley online library, 21.Https://bjui-journals.Onlinelibrary.Wiley.Com/doi/10.1111/bju.16173.Imdrf patient code e1310 is being used to capture the reportable issue of urinary tract infection.
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Search Alerts/Recalls
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