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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 No Display/Image (1183); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used in a flexible ureteroscopy procedure performed on (b)(6) 2021. During preparation, the lithovue flexscope was used and a hardware malfunction user message appeared on the screen. The patient had already received the maximum dose of propofol and the anesthesiologist did not authorize repeating the procedure on the same day. The procedure was cancelled due to this event. There was no serious injury/adverse effect to patient as a result of the event.
 
Manufacturer Narrative
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. However, it was reported the device was not used past its expiry date. (b)(4).
 
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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 Key13191809
MDR Text Key283616698
Report Number3005099803-2022-00040
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874812
UDI-Public08714729874812
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
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 Number0027216766
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2021
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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