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

Model Number 801-000

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12077039
• MDR Text Key: 258705411
• Report Number: 3005099803-2021-03071
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (y/n): N
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/25/2021
• Patient Sequence Number: 1