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

Model Number	791-100
Medical Device Problem Codes	Failure to Power Up (1476); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
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 that a lithovue touch pc was used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue touch pc was used and there was no image on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
Additional Manufacturer Narrative
Block h10: device problem code 3191 is being used to capture the reportable issue of cancelled procedure.Block h10: investigation results.An inspection of the returned lithovue touch pc showed no discrepancy.A functional evaluation noted that the lithovue touch pc confirmed there is a display on the touch panel.The monitor was left running for over an hour, rebooted, and the scope was unplugged.When the touch pc was powered on, it showed a clear live image.The test was done three times.The reported event of device does not turn on was not confirmed.This investigation is assigned a most probable conclusion code of no problem detected.This conclusion was selected because the reason for the device definitely does not turn on could not be duplicated/replicated during functional testing.It can be concluded that the product operates as intended with no issues.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 used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue touch pc was used and it did not have an image.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the 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 1242
• MDR Report Key: 11118054
• Report Number: 3005099803-2021-00003
• Device Sequence Number: 4042084
• Product Code: FGB
• UDI-Device Identifier: 08714729874522
• UDI-Public: 08714729874522
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 791-100
• Device Catalogue Number: 791-100
• Device Lot Number: BLV0672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1