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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
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Event Description
Lithovue single-use digital flexible ureteroscope was being used inside the operating room when the position knob broke off. No harm to patient. Health care providers had to open another lithovue device to finish surgical case.
 
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Brand NameLITHOVUE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12933029
MDR Text Key281735607
Report Number12933029
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberM0067913500
Device Catalogue NumberM0067913500
Device Lot Number27451578
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2021
Event Location Hospital
Date Report to Manufacturer12/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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