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

Model Number	M0067913600
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a procedure performed on (b)(6) 2024.During the procedure, the image was lost when the basket forceps was stuck in the ureter.Semi rigid ureteroscope was used to treat ureteral stone and removed the basket forceps.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a procedure performed on (b)(6) 2024.During the procedure, the image was lost when the basket forceps was stuck in the ureter.Semi rigid ureteroscope was used to treat ureteral stone and removed the basket forceps.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of absence of treatment.Block h11: investigation results the reported complaint was confirmed.When the lithovue flexscope was connected to the monitor, no live image was displayed, and the hardware malfunction screen was present, confirming the reported complaint, as no image from the scope was displayed.After disassembling the device handle, pressure was applied to the solder pads of the camera flex strip at the connection to the pcba.The applied pressure on the camera flex strip was able to temporarily restore image of the device.When pressure was released, the image was lost.The observed condition is indicative of a faulty solder joint.A device history record (dhr) review confirms the device met all manufacturing specifications.A risk review was completed and confirmed that the event of "no display" is defined in the risk documentation and is documented accordingly in the prr.Product analysis identified a display issue, which was caused by a faulty solder joint between the pcba and camera flex strip.Ncep-00154230 was initiated on 11oct2023 to further investigate the observed defect.The ncep was closed on 25jan2024.It was determined the cause of the event was the hot bar solder machine needed to be adjusted.As a corrective action a hot bar solder trouble shooting guide was created.The investigation is assigned a conclusion code of quality control deficiency, which indicates, problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19733936
• Report Number: 2124215-2024-38654
• Device Sequence Number: 12528280
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: (01)08714729874812(17)260109(10)33175961
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 01/09/2026
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Device Lot Number: 0033175961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown