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

Model Number	801-000
Medical Device Problem Codes	Failure to Power Up (1476); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
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 attempted to be used on (b)(6) 2021.Touch pc could not power on, tried different socket and still would not power on.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code a27 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h10: investigation results a visual evaluation of the returned lithovue touch pc noted it was in good condition.A functional evaluation noted that the touch pc failed to provide a live image.There were no error messages and a time out did not occur.When a lithovue scope was plugged into the lithovue touch pc it could not detect the connection.The connection process was repeated many times with no success.The failure of is not powering on could not be confirmed.Based on the condition of the returned device, engineers determined that the conclusion of is not powering on was not replicated during functional testing, but another issue was detected.The failure mode observed could be caused because the touch pc could not detect the connection of the scope.Boston scientific has determined the most probable cause of this complaint is cause traced to component failure.Therefore, it can be concluded that component related was the most probable cause of the complaint.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 touch pc was attempted to be used on (b)(6) 2021.Touch pc could not power on, tried different socket and still would not power on.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

• 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
• MDR Report Key: 12077039
• Report Number: 3005099803-2021-03071
• Device Sequence Number: 3427171
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: LV03342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1