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

Model Number	791-700
Medical Device Problem Codes	No Display/Image (1183); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
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 on may 01, 2020 that a lithovue touch pc was opened for use on (b)(6) 2020 in a ureteroscopy procedure.According to the complainant during procedure, the touch pc was powered on and the monitor displayed blank/black screen.The procedure was cancelled due to this event.There was no serious injury nor adverse effects to the patient reported as a result of the event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a lithovue touch pc was opened for use on (b)(6), 2020 in a ureteroscopy procedure.According to the complainant during procedure, the touch pc was powered on and the monitor displayed blank/black screen.The procedure was cancelled due to this event.There was no serious injury nor adverse effects to the patient reported as a result of the event.
Additional Manufacturer Narrative
Block h6: prorblem code 3191 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h10: investigation results a visual inspection of the returned lithovue touch pc showed no discrepancy.A functional test was performed and the touch pc booted up to a blank screen instead of the the sidewinder application screen.The reported blank/black screen 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 blank/black screen was most likely determined to be defective component inside the touch pc from the functional test performed and the analysis of the available information.This conclusion was selected because the failure observed is a random component failure without any design or manufacturing issue.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 on may 01, 2020 that a lithovue touch pc was opened for use on (b)(6) 2020 in a ureteroscopy procedure.According to the complainant that during procedure, the monitor was powered on but the screen was blank/black.The patient was already sedated and procedure was cancelled.There was no serious injury nor adverse effects to the patient reported as a result of the event.The device is returning for analysis.
Additional Manufacturer Narrative
Block h6: problem code 3191 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h10: investigation results: a visual inspection of the returned lithovue touch pc showed no discrepancy.A functional test was performed and the touch pc booted up to a blank screen instead of the sidewinder application screen.The reported blank/black screen 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 blank/black screen was most likely determined to be defective component inside the touch pc from the functional test performed and the analysis of the available information.This conclusion was selected because the failure observed is a random component failure without any design or manufacturing issue.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Block h10: correction: block e1 and block g3 country of event corrected to ireland based on review of the complaint record on 06dec2020.

• 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: 10066007
• Report Number: 3005099803-2020-01888
• Device Sequence Number: 17087772
• Product Code: FGB
• UDI-Device Identifier: 08714729891901
• UDI-Public: 08714729891901
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 12/07/2020

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 Model Number: 791-700
• Device Catalogue Number: 791-700
• Device Lot Number: LV01222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 12/06/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/21/2020; 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1