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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 Consequences Or Impact To Patient (2199)
Event Date 12/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used in a retrograde intrarenal surgery procedure performed on (b)(6) 2020. According to the complainant, during the procedure, it was reported the image was grainy due to a significant amount of bleeding. Another lithovue flexscope was opened however it was the same. Residual stones were left in the kidney. After two hours, the procedure was cancelled due to this event. There was no serious injury/adverse effect to patient as a result of the 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11151213
MDR Text Key226259770
Report Number3005099803-2021-00026
Device Sequence Number1
Product Code FGB
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 Model Number791-360
Device Catalogue Number791-360
Device Lot Number0026010495
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 Received12/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2020
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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