MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	791-100
Medical Device Problem Codes	No Display/Image (1183); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a lithovue touch pc was used during a kidney stone treatment procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue flexscope was connected to the monitor and a hardware malfunction error as well as scope disconnected error occurred.The monitor was unplugged and plugged back in however it did not resolve the issue.A second lithovue flexscope was opened and the same issue occurred.The lithovue scopes were tested with another lithovue monitor and worked fine therefore it was determined the issue was with the touch pc.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10514880
• Report Number: 3005099803-2020-03806
• Device Sequence Number: 19717614
• Product Code: FGB
• UDI-Device Identifier: 08714729874522
• UDI-Public: 08714729874522
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 791-100
• Device Catalogue Number: 791-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1