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

Model Number	791-700
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	06/17/2021
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 during a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, lithovue scope was connected to the monitor and booted up to windows 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 h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned lithovue touch pc was analyzed, and a visual evaluation noted that there were some minor scratches on hte pc frame and the back panel, one standoff screw is missing on the dvi cable connector, and one interface box bracket mount screw is missing.A functional evaluation noted that the lithovue touch pc confirmed touch panel pc leds turn on.The lithovue touch pc display was blank at power on.The touch pc booted up to the blank screen instead of the application screen.The reported event was confirmed.This investigation is assigned a most probable conclusion code of cause traced to component failure.This conclusion was selected because the reason for when connecting the lithovue device to the screen, it did not open the boston scientific logo only windows was conformed during functional testing.The conclusion is acceptable because the analysis of the available information in the complaint did not find/reveal 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use 91012672-02c / product label.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue touch pc was attempted to be used during a flexible ureteroscopy procedure performed on (b)(6) 2021.According to the complaint, during preparation, lithovue scope was connected to the monitor and booted up to windows screen.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue; attn: return products; st. paul MN 55112
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12167407
• Report Number: 3005099803-2021-03385
• Device Sequence Number: 3988865
• Product Code: FGB
• UDI-Device Identifier: 08714729891901
• UDI-Public: 08714729891901
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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
• Report Date (Section B): 04/14/2022

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: 791-700
• Device Catalogue Number: 791-700
• 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: 06/18/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown