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

Model Number	791-360
Medical Device Problem Codes	No Display/Image (1183); Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
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 flexscope was used in a flexible ureteroscopy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the lithovue flexscope was not recognized by the monitor and problem with lithovue flexscope user message appeared on the screen.There were no more scopes available at the time of this case.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
Additional Manufacturer Narrative
Block h10: device problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results a visual inspection of the returned lithovue flexscope was performed.Product analysis of the returned device confirmed.The device was found to have no image due to bad calibration.The calibration data was downloaded and found to be lost/corrupted.The device was recalibrated and displayed a clear, live image.There is no evidence to suggest the cause of the failure is related to manufacturing, design, or site specific.Therefore, the investigation conclusion code assigned is cause not established, indicating the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used in a flexible ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue flexscope was not recognized by the monitor and problem with lithovue flexscope user message appeared on the screen.There were no more scopes available at the time of this case.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 10219668
• Report Number: 3005099803-2020-02548
• Device Sequence Number: 16952098
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 11/10/2020

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 Expiration Date: 03/12/2022
• Device Model Number: 791-360
• Device Catalogue Number: 791-360
• Device Lot Number: 0025350507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1