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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 791-360
Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a retrograde intrarenal surgery procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the monitor showed very warm image and bright glares on the stones. The physician decided to reschedule the procedure. The procedure was cancelled due to this event. There were no patient complications reported as a result of this event.
 
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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 1242
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752-1242
5086834015
MDR Report Key11147880
MDR Text Key226071353
Report Number3005099803-2021-00045
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874812
UDI-Public08714729874812
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2021
Device Model Number791-360
Device Catalogue Number791-360
Device Lot Number0024396449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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