LithoVue M0067917000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729891901), received between May 18, 2020 and Mar 17, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS INTENDED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE LITHOVUE TOUCH PC COULD NOT RECOGNIZE THE FLEXSCOPE AND WAS SHOWING BOOT TO DESKTOP SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802916 ↗
• MalfunctionJul 14, 2021Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS ATTEMPTED TO BE USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT, DURING PREPARATION, LITHOVUE SCOPE WAS CONNECTED TO THE MONITOR AND BOOTED UP TO WINDOWS SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167407 ↗
• MalfunctionMay 20, 2021No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858200 ↗
• MalfunctionApr 12, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT LITHOVUE TOUCH PC WAS ATTEMPTED TO BE USED IN THE KUB DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, THE MONITOR WAS HAVING SIDEWINDER APPLICATION ERROR. THE MONITOR DID NOT BOOT UP TO BSC APPLICATION AUTOMATICALLY. THERE WERE NO OTHER LITHOVUE SCOPES AVAILABLE AND REUSABLE SCOPES WERE BROKEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653110 ↗
• MalfunctionNov 2, 2020Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE CAPITAL WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION BEFORE THE SURGERY, THE MONITOR DID NOT TURN ON. THEY TRIED TO TROUBLESHOOT THE MONITOR AFTER SEVERAL ATTEMPTS AND IT STILL DID NOT WORK. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10775240 ↗
• MalfunctionOct 29, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED IN AN RIRS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE TOUCH PC ALTHOUGH THE POWER CABLE WAS CONNECTED AND THE POWER WAS ON. THERE WERE NO MORE SCOPES AVAILABLE AT THE TIME OF THIS CASE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10756165 ↗
• MalfunctionSep 1, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE LITHOVUE FLEXSCOPE WAS CONNECTED THE LITHOVUE TOUCH PC DID NOT DISPLAY 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476399 ↗
• MalfunctionJul 14, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE TOUCH PC WAS TURNED ON HOWEVER THE SCREEN PRODUCED NO IMAGE. THE LITHOVUE TOUCH PC WAS REBOOTED AND STILL DID NOT PRODUCE AN IMAGE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. AFTERWARDS THE PHYSICIAN TRIED TO TEST THE LITHOVUE TOUCH PC BY USING A DVI CABLE AND THE IMAGE SHOWED ON AN EXTERNAL MONITOR WHILE THE LITHOVUE TOUCH PC STILL HAD NO IMAGE. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10269923 ↗
• MalfunctionJul 6, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 10, 2020 THAT A LITHOVUE CAPITAL WAS OPENED AND USED ON (B)(6) 2020 IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE NURSE CONNECTS THE SCOPE TO THE MONITOR AND IT DID NOT SHOW AN IMAGE AFTER INSPECTING THEY NOTICED THAT THE BLUE LOCKING NUT THAT HOLDS THE SCOPE WAS CRACKED.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. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10235435 ↗
• MalfunctionJul 6, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE TOUCH PC WAS USED DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE FLEXSCOPE WAS CONNECTED TO THE MONITOR AND THE SCREEN REMAINED BLACK. THERE WAS NO IMAGE THAT APPEARED 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233851 ↗
• MalfunctionMay 18, 2020No Display/Image; Appropriate Device Problem Term/Code Not Available; No Display/Image; Appropriate Device Problem Term/Code Not Available

  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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10066007 ↗