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

Model Number 791-700

Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)

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

Event Date 05/06/2021

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 used in a procedure performed on (b)(6) 2021.During the procedure, the lithovue touch pc was displaying a black screen.The monitor would not work and there were no reusable scopes available at the time of this case.The procedure was cancelled due to this event.There were no patient complications as a result of the event.

Manufacturer Narrative

Block h6: medical device problem code a27 is being used to capture aborted/cancelled procedure.Block h10: investigation results the returned lithovue touch pc was analyzed and visual inspection of the touch pc showed no damage and the product has passed visual inspection.A functional test was performed on the pc and it booted to a black screen.There was no visual display from the touch pc.This investigation is assigned a most probable conclusion code of cause traced to component failure.During the functional test, lithovue touch pc booted to a black screen and there was no visual display.The most likely cause is components in the pc.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, the reported event was confirmed.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 used in a procedure performed on (b)(6) 2021.During the procedure, the lithovue touch pc was displaying a black screen.The monitor would not work and there were no reusable scopes available at the time of this case.The procedure was cancelled due to this event.There were no patient complications as a result of the event.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11858200
• MDR Text Key: 251984701
• Report Number: 3005099803-2021-02381
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729891901
• UDI-Public: 08714729891901
• 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: 09/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 791-700
• Device Catalogue Number: 791-700
• Device Lot Number: LV01090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1