LithoVue M0067913600Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729874812), received between Oct 24, 2017 and Sep 10, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026No Display/Image

  It was reported that during the procedure, when the scope was connected no image displayed on the screen. The procedure was cancelled and rescheduled. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713511 ↗
• MalfunctionJul 22, 2024No Display/Image; Device Displays Incorrect Message; Connection Problem; Adverse Event Without Identified Device or Use Problem; No Display/Image; Device Displays Incorrect Message; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE USING A LITHOVUE FLEXSCOPE, A USER MESSAGE APPEARED ON THE SCREEN AND THE SHEATH WAS TOO BIG TO ENTER THE URETER. THE PROCEDURE WAS CANCELLED AS THE PHYSICIAN DO NOT WANT TO PERFORM THE PROCEDURE WITHOUT AN ACCESS SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED. THIS IS BEING REPORTED FOR AN ABORTED PROCEDURE WITH THE PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795659 ↗
• MalfunctionJul 12, 2024No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE IMAGE WAS LOST WHEN THE BASKET FORCEPS WAS STUCK IN THE URETER. SEMI RIGID URETEROSCOPE WAS USED TO TREAT URETERAL STONE AND REMOVED THE BASKET FORCEPS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733936 ↗
• MalfunctionJun 14, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SEAL OF THE SCOPE WAS COMPROMISED. TO COMPLETE THE PROCEDURE, A NEW SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19540610 ↗
• MalfunctionMay 27, 2024No Display/Image; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; No Display/Image; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE PREPARATION, THE SCOPE WAS PLUGGED INTO THE MONITOR AND "PROBLEM WITH LITHOVUE FLEXSCOPE" USER MESSAGE APPEARED ON THE SCREEN. THERE WERE NO AVAILABLE SCOPES TO BE USED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400932 ↗
• MalfunctionFeb 26, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A FLEXI URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE LITHOVUE FILM WAS NOT ATTACHED WHEN REMOVED FROM THE BOX AND WAS ASSUMED TO BE NON-STERILE. THE PROCEDURE WAS COMPLETED WITH A SECOND LITHOVUE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776903 ↗
• MalfunctionAug 14, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, UROLOGIST WAS UNABLE TO ADVANCE SCOPE. HE DILATED URETER WITH DUAL LUMEN AND INNER STYLET OF 11/13. HE PLACED A STENT AFTER SCOPE WAS UNABLE TO ADVANCE AND THE PROCEDURE WAS CANCELLED/RESCHEDULED. THE PROCEDURE WAS NOT COMPLETED 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 17546522 ↗
• MalfunctionMay 23, 2023No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, THE FLEXSCOPE WOULD NOT SHOW AN IMAGE, AND A "HARDWARE MALFUNCTION" USER MESSAGE APPEARED ON THE SCREEN. REPORTEDLY, THE PHYSICIAN WAS NOT CERTAIN IF THE PROBLEM OCCURRED WITH THE FLEXSCOPE OR THE TOUCH PC, SO THEY DECIDED TO STENT THE PATIENT AND RESCHEDULE THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT IF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983228 ↗
• InjuryMay 5, 2023Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A CYSTOSCOPY, LEFT URETEROSCOPY WITH LASER LITHOTRIPSY AND BASKET STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS A LEFT URETERAL STENT EXCHANGE, RIGHT URETERAL STENT REMOVAL AND LEFT RETROGRADE PYELOGRAM. WHILE PERFORMING LASER LITHOTRIPSY ON THE LEFT URETER/KIDNEY A THIN METAL LIKE FOREIGN BODY WAS FOUND DURING THE FLUSHING PROCESS. IT WAS REPORTED THE LITHOVUE FLEXSCOPE HAD THE TIP SHEARED OFF. IN THE PHYSICIANS ASSESSMENT THE METAL PIECE CAME FROM EITHER THE RETRIEVAL BASKET (UNKNOWN MANUFACTURER) OR THE SCOPE BUT DID OCCUR DURING THE PROCEDURE. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: DO NOT WITHDRAW A LASER FIBER BACK INTO THE URETEROSCOPE WHILE THE LASER IS FIRING. DOING SO MAY CAUSE PATIENT INJURY AND/OR SCOPE DAMAGE. INSERTING AND REMOVING AN ACCESSORY AND APPLICATION OF THERAPY NOTE: IF USING A LASER LITHOTRIPSY SYSTEM, SELECT A SYSTEM WHICH FEATURES AN AIMING BEAM WITH ADJUSTABLE INTENSITY OR PULSE OPTION. ADJUST AIMING BEAM INTENSITY OR PULSATION TO ALLOW CLEAR LIVE VIDEO IMAGE OF THE LITHOTRIPSY TARGET. DO NOT ACTUATE ANY ACCESSORY DEVICE, I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878380 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE, THE EFFICIENCY OF MOSES TECHNOLOGY HOLMIUM LASER FOR TREATING RENAL STONES DURING FLEXIBLE URETEROSCOPY: RELATIONSHIP BETWEEN STONE VOLUME, TIME, AND ENERGY. IT WAS EXAMINED THE RELATIONSHIP OF STONE VOLUME AND DENSITY TO LITHOTRIPSY, LASING TIMES, AND ENERGY USED TO TREAT A SINGLE RENAL STONE. OUT OF THE TWENTY-NINE PATIENTS INVOLVED IN THE STUDY, SOME PATIENTS HAD POSTOPERATIVE COMPLICATIONS. THREE (10.3%) HAD A CLAVIEN-DINDO GRADE 1 COMPLICATION. ONE PATIENT MADE AN OFFICE PHONE CALL FOR STENT-RELATED PAIN TREATED WITH ANALGESICS. TWO PATIENTS HAD AN ED VISIT, ONE FOR URINARY RETENTION TREATED WITH A FOLEY CATHETER AND REMOVED IN THE OFFICE. THE SECOND PATIENT HAD FLANK PAIN, RESOLVED WITH EARLY REMOVAL OF THE STENT. NO PATIENTS REQUIRED UNPLANNED SURGICAL INTERVENTION.

  Patient problems: Fever; Pain; Unspecified Infection; Urinary Retention

  MAUDE report 15574045 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE SCOPE WAS USED IN THE KIDNEY DURING A LEFT URETEROSCOPY, LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT HAD A PROCEDURE DONE WITH A 6FR 24CM STENT WITH STRING IMPLANTED AND WAS REMOVED FOUR DAYS AFTER THE PROCEDURE. THE PATIENT EXPERIENCED MILD DISCOMFORT IN THE RIGHT QUADRANT AND WAS TREATED WITH SYMPTOMATIC TREATMENT. THE PATIENT ALSO EXPERIENCED MALAISE, WEAKNESS, AND NAUSEA ONE WEEK AFTER THE PROCEDURE, AND IT GOT WORSE AT HOME WHEN THE PATIENT DEVELOPED DYSPNEA AND CHEST PAIN. THE PATIENT WAS RUSHED TO THE EMERGENCY ROOM AND GOT ADMITTED. IN THE EMERGENCY ROOM, RESULTS SHOWED THAT THE PATIENT HAD HYPOTENSIVE BP 92 62 AND HYPOXIC OXYGEN SATURATION OF 87 PERCENT. IMMEDIATE LABS REVEALED ELEVATED LEUKOCYTOSIS WBC, 13700 PER L, AZOTEMIA CR 1.53MG DL, AND POSITIVE BLOOD AND URINE CULTURES, BOTH GROWING KLEBSIELLA PNEUMONIAE. A COMPUTED TOMOGRAPHY WAS PERFORMED IN THE ABDOMEN AND FOUND A 5 CM RIGHT UPPER POLE AND A 3 CM RIGHT MID POLE RENAL ABSCESS WITH PARENCHYMAL AIR APPEARING AS A HYPODENSE AREA. THE PATIENT WAS ALSO DIAGNOSED WITH RIGHT EMPHYSEMATOUS PYELONEPHRITIS WITH

  Patient problems: Abscess; Chest Pain; Discomfort; Dyspnea; Low Blood Pressure/ Hypotension; Malaise; Muscle Weakness/Atrophy; Nausea; Sepsis; Unspecified Infection

  MAUDE report 15565354 ↗
• InjuryAug 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A KIDNEY STONE REMOVAL WITH LASER PROCEDURE PERFORMED ON (B)(6) 2022. DURING WITHDRAWAL, THE LITHOVUE SCOPE TIP WAS LOCKED IN A 270 DEGREES DEFLECTED STATE WHICH WAS REMOVED BY CUTTING THE SHAFT AND THE PATIENT EXPERIENCED BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15203456 ↗
• MalfunctionJan 20, 2022No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, THE SCOPE WAS CONNECTED TO THE MONITOR AND "HARDWARE MALFUNCTION" USER MESSAGE APPEARED ON THE 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 13308772 ↗
• MalfunctionJan 7, 2022No Display/Image; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; No Display/Image; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; 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) 2021. DURING PREPARATION, THE LITHOVUE FLEXSCOPE WAS USED AND A HARDWARE MALFUNCTION USER MESSAGE APPEARED ON THE SCREEN. THE PATIENT HAD ALREADY RECEIVED THE MAXIMUM DOSE OF PROPOFOL AND THE ANESTHESIOLOGIST DID NOT AUTHORIZE REPEATING THE PROCEDURE ON THE SAME DAY. 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 13191809 ↗
• MalfunctionJan 4, 2022Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THERE WAS A LOT OF BLEEDING IN THE KIDNEY. IN THE PHYSICIANS ASSESSMENT THIS WAS MOST LIKELY DUE TO PREVIOUS STENTING OR INSERTING OF ACCESS SHEATH. BASED UPON THE BLOOD THE IMAGE ON THE LITHOVUE WAS ONLY SHOWING RED AND BRIGHT YELLOW. THE PHYSICIAN DECIDED TO PUT IN A STENT AND HAVE THE PATIENT COME BACK ANOTHER DAY. THE PROCEDURE WAS RESCHEDULED 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 13156059 ↗
• MalfunctionJun 9, 2021No Display/Image; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; No Display/Image; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO SECOND OF TWO LITHOVUE FLEXSCOPES USED IN THE SAME PATIENT AND PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-02734 FOR THE FIRST 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964798 ↗
• MalfunctionJun 9, 2021No Display/Image; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; No Display/Image; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964747 ↗
• MalfunctionJan 11, 2021Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS REPORTED THE IMAGE WAS GRAINY DUE TO A SIGNIFICANT AMOUNT OF BLEEDING. ANOTHER LITHOVUE FLEXSCOPE WAS OPENED HOWEVER IT WAS THE SAME. RESIDUAL STONES WERE LEFT IN THE KIDNEY. AFTER TWO HOURS, 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 11151213 ↗
• MalfunctionJan 11, 2021Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MONITOR SHOWED VERY WARM IMAGE AND BRIGHT GLARES ON THE STONES. THE PHYSICIAN DECIDED TO RESCHEDULE THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11147880 ↗
• MalfunctionDec 23, 2020Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE FLEXSCOPE HAD POOR VISION AND THE LIGHT WAS FLASHING. 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 11064939 ↗
• MalfunctionDec 16, 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 TRANSURETHRAL URETERAL STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LITHOVUE FLEXSCOPE WOULD NOT DISPLAY AN IMAGE. WHEN THE SCOPE WAS DISCONNECTED AND RE-PLUGGED IN THE IMAGE WAS RESTORED. THEN THE IMAGE DISAPPEARED AGAIN AND PROCEDURE WAS DISCONTINUED. 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; No Consequences Or Impact To Patient

  MAUDE report 11015456 ↗
• 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 THE KIDNEY, URETER, AND BLADDER DURING A RETROGRADE INTRARENAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SCOPE WAS UNSTABLE IN DELIVERING IMAGE TO THE MONITOR AND THE SCREEN DISPLAYED INTERMITTENT IMAGE. REPORTEDLY, THE PROCEDURE WAS GETTING TOO LONG AND THERE ARE MANY MORE STONES TO CLEAR. PHYSICIAN DECIDED TO REVISIT THE CASE ON ANOTHER DAY. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477526 ↗
• MalfunctionJul 1, 2020No Display/Image; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; No Display/Image; Device Displays Incorrect Message; 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 THE PROCEDURE, THE LITHOVUE FLEXSCOPE WAS NOT RECOGNIZED BY THE MONITOR AND PROBLEM WITH LITHOVUE FLEXSCOPE USER MESSAGE APPEARED ON THE SCREEN. 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 10219668 ↗
• MalfunctionJun 4, 2020Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOVUE FLEXSCOPE WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON M(B)(6) 2020. ACCORDING TO THE COMPLAINANT, TOWARDS THE END OF THE PROCEDURE THE MONITOR SHOWED BAD COLORING AND HAD GLARE ISSUES. REPORTEDLY, THE PHYSICIAN COULD NOT VISUALIZE WHICH WAS THE STONE AND WHICH WAS THE MUCOSAL WALL. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10119120 ↗
• MalfunctionSep 18, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 23, 2018 THAT A LITHOVUE FLEXSCOPE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PACKAGE WAS NOT COMPLETELY SEALED AND THE LITHOVUE SCOPE INSIDE WAS CONSIDERED TO BE UNSTERILE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886946 ↗