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

Model Number	801-000
Medical Device Problem Codes	No Display/Image (1183); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue touch pc was used in a fursl procedure performed on (b)(6) 2022.During the procedure, the lithovue touch pc showed hardware error user message on the screen.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h06 (impact code): impact code f05 is being used to capture the reportable issue of aborted or cancelled procedure.Block h10: a visual inspection of the returned lithovue touch pc showed no discrepancy.A functional test was performed, and the touch pc was fully functional.The reported "an error with their lithovue monitor.It is coming up with hardware error and is not working" was not confirmed during investigation.This investigation is assigned a most probable conclusion code of "no problem detected".This conclusion was selected because the alleged touch panel pc "an error with their lithovue monitor.It is coming up with hardware error and is not working" didn't happen while running for over two hours.The conclusion "no problem detected" is acceptable because the analysis of the available information in the complaint did not find any fault condition within the product.The evidence from the product record review did not identify a potential product quality issue or new patient harm.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue touch pc was used in a fursl procedure performed on (b)(6) 2022.During the procedure, the lithovue touch pc showed hardware error user message on the screen.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue touch pc was used in a fursl procedure performed on (b)(6) 2022.During the procedure, the lithovue touch pc showed hardware error user message on the screen.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h06 (impact code): impact code f05 is being used to capture the reportable issue of aborted or cancelled procedure.Block h10: a visual inspection of the returned lithovue touch pc showed no discrepancy.A functional test was performed, and the touch pc was fully functional.The unit completed 3 power off/on cycles and the unit booted to lithovue software application every time.Touch pc showed error message with red circle on the second power one and off; once the error is cleared, the unit didn't display the error again.It can be concluded that the reported "an error with their lithovue monitor.It is coming up with hardware error and is not working" was confirmed for showing error intermittently when powered on and off.This investigation is assigned a most probable conclusion code of "cause traced to component failure".This conclusion was selected because the alleged touch panel pc "an error with their lithovue monitor.It is coming up with hardware error and is not working" did happen intermittently during power on off step of the investigation.The conclusion "cause traced to component failure" is acceptable because the unit intermittently shows error.The analysis of the available information in the complaint did not find any other fault condition within the product.The evidence from the product record review did not identify a potential product quality issue or new patient harm.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The shipping review confirmed that the devices met all material, assembly and performance specifications.

• Brand Name: LITHOVUE SYSTEM WORKSTATION
• 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; 150 baytech dr.; attn: return products; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 15211167
• Report Number: 3005099803-2022-04498
• Device Sequence Number: 2067652
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2023

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: 801-000
• Device Catalogue Number: 801-000
• Device Lot Number: LV03528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 11/15/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/13/2022; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown