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

Model Number 791-360

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Note: this report pertains to first of two lithovue flexscopes used in the same patient and procedure.Refer to manufacturer report number mfr.Report # 3005099803-2021-02733 for the second scope.It was reported to boston scientific corporation that two lithovue flexscopes were used in the kidney during a flexible ureteroscopy procedure performed on (b)(6) 2021.During procedure, one lithovue flexscope was plugged into the monitor and a hardware malfunction user message appeared on the screen.Another of the same scope was plugged in and the same message appeared.The procedure was cancelled due to this event.There were no patient complications reported as a result of this 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11964747
• MDR Text Key: 255104227
• Report Number: 3005099803-2021-02734
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: 791-360
• Device Catalogue Number: 791-360
• Device Lot Number: 0026997025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1