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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M0067913500
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/17/2025
Type of Reportable Event Malfunction
Event or Problem Description
During the procedure, the disposable scope's deflection tip broke while being used with the laser.A new disposable scope was used and switched on but could not be used because the blue lever was broken.A third scope was then used for the case.No patient harm.
 
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Brand Name
LITHOVUE
Common Device Name
URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key23412816
Report Number23412816
Device Sequence Number21427790
Product Code FGB
UDI-Device Identifier08714729874805
UDI-Public(01)08714729874805(17)270620(10)40341642
Combination Product (Y/N)N
Initial Reporter StateCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/08/2025
Report Date (Section F) 10/08/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM0067913500
Device Catalogue NumberM0067913500
Device Lot Number40341642
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer10/29/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/29/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient Age77 YR
Patient SexMale
Patient Weight62 KG
Date Report Sent to FDA10/08/2025
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