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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 791-700
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that lithovue touch pc was attempted to be used in the kub during a ureteroscopy procedure performed on (b)(6) 2021. During the procedure, the lithovue touch pc did not boot up to the boston scientific application automatically; there was a sidewinder application error. The facility had no other devices available to complete the procedure therefore 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
150 baytech dr.
san jose CA 95134
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11653110
MDR Text Key245550291
Report Number3005099803-2021-01657
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number791-700
Device Catalogue Number791-700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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