EXALT™ M00542430Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729990901), received between Dec 19, 2022 and Jun 29, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (38 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 16, 2021Terminated

   May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

   Z-1492-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF A BILIARY OBSTRUCTION. DURING THE PROCEDURE THE IMAGE WOULD FLICKER CAUSING LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661271 ↗
• MalfunctionMay 15, 2026Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR AN UNKNOWN TREATMENT. DURING THE PROCEDURE, IMAGE WAS LOST INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITH A NEW EXALT MODEL D SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186860 ↗
• MalfunctionJan 9, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO AN EXALT D CONTROLLER USED WITH TWO EXALT MODEL D SCOPES IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXALT MODEL D SCOPES WERE USED WITH AN EXALT CONTROLLER DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCOPE MALFUNCTIONED AND THE IMAGE APPEARS FOR A FEW SECONDS AND THEN BLACKED OUT. A SECOND EXALT SCOPE WAS USED AND THE SAME MALFUNCTION OCCURRED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 14, 2026 CONFIRMING THAT THE PROCEDURE DATE WAS (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021218 ↗
• MalfunctionJan 8, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT MODEL D CONTROLLER THE CUSTOMER REPORTED THE IMAGE FLICKER, TURNED TO BLACK AND LATER WAS RESTORED. THIS EVENT OCCURRED ONE TO TWO TIMES DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE ORIGINAL EXALT D CONTROLLER AND EXALT D SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012196 ↗
• MalfunctionDec 12, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL D CONTROLLER WAS USED WITH AN EXALT MODEL D SCOPE IN A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, VISUALIZATION WAS LOST. THE EXALT CONTROLLER WAS RESTARTED AND VISUALIZATION RETURNED. TROUBLESHOOTING DETERMINED THAT RECONNECTING A VIDEO CABLE RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792293 ↗
• MalfunctionNov 26, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06440 FOR THE EXALT MODEL D SCOPE AND 3005099803-2025-06220 FOR THE EXALT D CONTROLLER. IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT CONTROLLER SHUTDOWN AND VISUALIZATION WAS LOST. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655714 ↗
• MalfunctionNov 25, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06439 FOR THE EXALT MODEL D SCOPE AND 3005099803-2025-06219 FOR THE EXALT D CONTROLLER. IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT CONTROLLER SHUTDOWN AND VISUALIZATION WAS LOST. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23651580 ↗
• MalfunctionNov 25, 2025Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Optical Problem; Unexpected Shutdown; Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Optical Problem; Unexpected Shutdown

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06490 FOR THE EXALT MODEL D SCOPE AND 3005099803-2025-06489 FOR THE EXALT D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CONTROLLER STOPPED WORKING AND VISUALIZATION WAS LOST. THE CONTROLLER WAS RESTARTED TWICE BUT WOULD NOT POWER UP, TROUBLESHOOTING CONFIRM POWER SUPPLY CABLES WERE PROPERLY CONNECTED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647651 ↗
• MalfunctionAug 25, 2025Connection Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER: 3005099803-2025-04313 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER: 3005099803-2025-04177 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL D SINGLE USE DUODENOSCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT MODEL D SCOPE WAS INTERMITTENTLY UNABLE TO BE DETECTED BY THE CONTROLLER. VISUALIZATION WAS LOST WHILE THE SCOPE WAS IN THE PATIENT. ADDITIONALLY, THE CONNECTION BETWEEN SCOPE AND CONSOLE FELT LOOSE AND THE CLICKING SOUND FOR SCOPE CONNECTION WAS VERY FAINT. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883456 ↗
• MalfunctionJul 3, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL D CONTROLLER WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT MODEL D CONTROLLER SHUT DOWN. IT WAS REPORTED THAT THE CONNECTION FROM POWER CORD TO CONTROLLER IS FAULTY. THE LIGHTS ON THE CONTROLLER FLICKER WHEN THE CONTROLLER IS CONNECTED AND IT REMAINS UNRESPONSIVE. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395132 ↗
• MalfunctionOct 28, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-05336 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER . FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED WITH AN EXALT MODEL D SCOPE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024, FOR THE TREATMENT OF STONES IN THE COMMON BILE DUCT. DURING THE PROCEDURE, THE SCREEN TURNED PURPLE. THE EXALT CONTROLLER WAS TURNED ON AND OFF, UNPLUGGED AND PLUGGED BACK IN BUT THE ISSUE WAS NOT RESOLVED. THE LIGHT SOURCE STOPPED WORKING AND NO PICTURE CAME ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544022 ↗
• MalfunctionOct 18, 2024Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-05273 FOR THE EXALT MODEL D CONTROLLER AND MANUFACTURER REPORTS NUMBER 3005099803-2024-05274, 3005099803-2024-05275, 3005099803-2024-05276 AND 3005099803-2024-05277 FOR THE EXALT MODEL D SCOPES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED WITH FOUR EXALT MODEL D SCOPES, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN ERROR SCREEN APPEARED AND BLACK HORIZONTAL LINES ACROSS THE SCREEN APPEARED. THE SCOPES WERE SWITCHED, BUT THE BLACK HORIZONTAL LINES ACROSS THE SCREEN PERSISTED. THE PROCEDURE WAS COMPLETED WITH ONE OF THE REPORTED EXALT MODEL D SCOPES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486783 ↗
• MalfunctionOct 14, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-05091 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. AN HOUR INTO THE PROCEDURE, A LOADING SCREEN APPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT D SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444796 ↗
• MalfunctionSep 30, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04859 FOR THE EXALT MODEL D SCOPE AND FOR THE EXALT D CONTROLLER. IT WAS REPORTED THAT AN EXALT D CONTROLLER WAS USED WITH AN EXALT MODEL D SINGLE USE DUODENOSCOPE FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. THE CONTROLLER HAS SHOWN MULTIPLE INSTANCES WHERE VISUALIZATION WAS LOST, AND THE LOADING SCREEN APPEARED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334692 ↗
• MalfunctionSep 27, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04803 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SCOPE STOPPED WORKING AND AN ERROR SCREEN APPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325902 ↗
• MalfunctionSep 26, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04799 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-04804 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SCOPE STOPPED WORKING AND AN ERROR SCREEN APPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312245 ↗
• MalfunctionSep 19, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04652 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-04651 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN SHOWED AN ERROR SCREEN AND VISUALIZATION WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258268 ↗
• MalfunctionSep 19, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04649 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-04648 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN SHOWED AN ERROR SCREEN AND VISUALIZATION WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257747 ↗
• MalfunctionSep 19, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04641 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN SHOWED AN ERROR SCREEN AND VISUALIZATION WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257247 ↗
• MalfunctionSep 19, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04638 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-04637 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN SHOWED AN ERROR SCREEN AND VISUALIZATION WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257223 ↗
• MalfunctionSep 19, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04627 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-04626 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN SHOWED AN ERROR SCREEN AND VISUALIZATION WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257183 ↗
• MalfunctionAug 13, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-03906 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-03905 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT D CONTROLLER WAS USED WITH AN EXALT D SCOPE, DURING AN UNKNOWN DIAGNOSIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SCREEN CHANGED COLOR TO PURPLE, ORANGE AND THEN SCREEN BLANKED OUT WITH NO IMAGE AT ALL. THE CONTROLLER WAS REBOOTED BUT THE IMAGE WAS NOT RECOVERED. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976976 ↗
• MalfunctionJul 1, 2024Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-03043 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-03002 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE EXALT MODEL D CONTROLLER TURNED OFF AND RESTARTED ON ITS OWN. THIS HAPPENED 3 TO 4 TIMES, THE CONTROLLER WORKED FOR A COUPLE MINUTES IN BETWEEN RESTARTS. THE PHYSICIAN LET THE CONTROLLER START UP AGAIN EACH TIME AND CONTINUED TO TRY TO USE THE EXALT SCOPE UNTIL IT WAS DECIDED TO SWITCH TO A REUSABLE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE REUSABLE SCOPE AND WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650259 ↗
• MalfunctionMar 28, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01335 FOR THE EXALT MODEL D CONTROLLER, AND 3005099803-2024-01375 FOR THE EXALT MODEL D SCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED ON AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE EXALT MODEL D CONTROLLER SHUT DOWN MID PROCEDURE ON MULTIPLE OCCASIONS. THE CONTROLLER WAS THEN POWERED ON AGAIN TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994589 ↗
• MalfunctionMar 20, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01035 FOR THE EXALT MODEL D SCOPE. IT WAS REPORTED THAT AND EXALT MODEL D CONTROLLER WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING PROCEDURE, THE IMAGE WAS LOST AND WAS UNABLE TO BE RECOVERED AFTER MULTIPLE ATTEMPTS OF POWERING ON. THE CONTROLLER WOULD NOT POWER ON. THE ACCOUNT SWITCHED TO A REUSABLE SCOPE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941033 ↗