EXALT™ Model D M0054242CE0Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729995746), received between Oct 1, 2020 and Feb 24, 2026 — classified as 1 death, 5 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (20 reports).

4 FDA recall records name this device's identifier, 4 still open.

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. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0397-2024 · Root cause: Process control · FDA record ↗

2. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0396-2024 · Root cause: Process control · FDA record ↗

3. Mar 3, 2022Open, Classified

   Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

   Z-1081-2022 · Root cause: Device Design · FDA record ↗

4. Mar 3, 2022Open, Classified

   Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

   Z-1082-2022 · Root cause: Device Design · 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.

• MalfunctionFeb 24, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON AN UNKNOWN DATE FOR THE TREATMENT OF A STRICTURE. DURING THE PROCEDURE, WHILE THE SCOPE WAS IN FRONT OF THE PAPILLA, THE VIDEO IMAGE WAS LOST AND THE SYSTEM DISPLAYED THE LOADING SCREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND 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 24431774 ↗
• MalfunctionOct 7, 2025Optical Problem; Optical Problem

  IT WAS REPORTED AN EXALT MODEL D SCOPE WAS UTILIZED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, THE PICTURE AND THE LIGHT STOP WORKING. THE NURSE CHANGED TO A NEW SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23237629 ↗
• MalfunctionSep 17, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED TO TREAT STRICTURES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, VISUALIZATION WAS LOST WHILE THE SCOPE WAS POSITIONED IN FRONT OF THE PAPILLA. THE MONITOR DISPLAYED A LOADING SCREEN THAT DID NOT RECOVER. TROUBLESHOOTING STEPS WERE PROMPTLY INITIATED, INCLUDING DISCONNECTING AND RECONNECTING THE SCOPE, SECURING THE REAR CONNECTION, AND RESTARTING THE CONTROLLER. THE SCOPE'S UMBILICUS WAS CONFIRMED TO BE SECURELY CONNECTED TO THE UMBILICUS RECEPTACLE OF THE CONTROLLER, WITH NO DAMAGE NOTED TO EITHER THE RECEPTACLE OR THE CABLES. THE PROCEDURE WAS COMPLETED USING ANOTHER EXALT MODEL D SCOPE, CONNECTED TO THE SAME CONTROLLER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076863 ↗
• MalfunctionMay 14, 2025Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-02078 FOR EXALT MODEL D SCOPE AND 3005099803-2025-02206 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) 2025. DURING THE PROCEDURE, THE IMAGE WAS BLURRY AND COULD NOT BE CLEARED WITH IRRIGATION. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE, A REUSABLE SCOPE WAS USED FOR VERIFICATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021330 ↗
• MalfunctionMay 7, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE THE VISUALIZATION WAS LOST, THE SCREEN WENT BACK TO THE HOME SCREEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977897 ↗
• MalfunctionOct 29, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024, FOR THE TREATMENT OF BILIARY STRICTURE. DURING THE PROCEDURE, THE IMAGE BEGAN TO FLICKER. THE CONTROLLER WAS TURNED OFF AND BACK ON AND THE ISSUE WENT AWAY FOR ABOUT 5 MINUTES BEFORE BEGINNING AGAIN. THE IMAGE THEN COMPLETELY WENT AWAY. 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 20560041 ↗
• MalfunctionMar 20, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT AN EXALT MODEL D SINGLE USE SCOPE WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AT AN UNKNOWN DATE. DURING THE PROCEDURE, THE IMAGE QUALITY DETERIORATED. THE PROCEDURE WAS COMPLETED WITH A SECOND EXALT SCOPE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944479 ↗
• MalfunctionFeb 22, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED ON AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USED TO TREAT STRICTURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, VISUALIZATION WAS LOST. THE PROCESSOR SHUT DOWN AND WOULD NOT RESTART. THE PHYSICIAN SWITCHED TO A NEW EXALT MODEL D SCOPE, AND BOTH THE PROCESSOR AND NEW SCOPE FUNCTIONED AS INTENDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760608 ↗
• MalfunctionJan 22, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. REPEATEDLY THROUGHOUT THE PROCEDURE, VISUALIZATION WAS LOST AND THE LOADING SCREEN APPEARED. THE PHYSICIAN UNPLUGGED AND RE-PLUGGED THE SCOPE, BUT THE ISSUE WAS NOT RESOLVED. A SECOND EXALT SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556121 ↗
• MalfunctionDec 26, 2023Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-06888 FOR THE EXALT MODEL D SCOPE AND 3005099803-2023-07082 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED ON AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USED TO TREAT STONES IN THE BILE DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, VISUALIZATION WAS LOST WHEN THE LOADING SCREEN APPEARED, FOLLOWED BY THE SCOPE ERROR SCREEN. THE PROCEDURE WAS ABLE TO BE FINISHED USING THE ORIGINAL DEVICE HOWEVER, IT HAD TO BE RESTARTED MULTIPLE TIMES. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395152 ↗
• MalfunctionDec 18, 2023Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR TREATMENT OF STONES ON (B)(6) 2023. AT TWO TIMES DURING THE PROCEDURE, VISUALIZATION WAS LOST AND THE LOADING SCREEN APPEARED. AFTER UNPLUGGING THE SCOPE AND RECONNECTING IT, VISUALIZATION WAS RESTORED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343858 ↗
• MalfunctionDec 15, 2023Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED ON AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USED TO TREAT A NEOPLASM PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DUODENOSCOPE HAD A VERY POOR, GRAINY AND BLURRY VISION. THE PHYSICIAN WASN'T ABLE TO SEE ALMOST ANYTHING WHILE HE WAS DESCENDING TO THE DUODENUM AND ALSO THE PAPILLA VISION WAS VERY POOR. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL SCOPE AND THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337940 ↗
• MalfunctionDec 12, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MANAGEMENT OF STONES ON (B)(6) 2023. DURING THE PROCEDURE, VISUALIZATION WAS LOST AND THE SCOPE ERROR SCREEN APPEARED ON THE MONITOR. THE EXALT MODEL D CONTROLLER WAS RESTARTED MULTIPLE TIMES. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE ORIGINAL SCOPE USING X-RAY VISUALIZATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311830 ↗
• MalfunctionNov 9, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SCOPE'S ELEVATOR PRODUCED A REFLECTION THAT PRESENTED AS A SPOT IN THE SCOPE'S FIELD OF VIEW. THE PHYSICIAN REPORTED THAT ALTHOUGH THE LIMITED VIEW MADE THE PROCEDURE MORE CHALLENGING, IT WAS SUCCESSFULLY COMPLETED USING THE SAME SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099737 ↗
• MalfunctionNov 8, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE.DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SCOPE'S ELEVATOR PRODUCED A REFLECTION THAT PRESENTED AS A SPOT IN THE SCOPE'S FIELD OF VIEW. THE PHYSICIAN REPORTED THAT ALTHOUGH THE LIMITED VIEW MADE THE PROCEDURE MORE CHALLENGING, IT WAS SUCCESSFULLY COMPLETED USING THE SAME SCOPE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093308 ↗
• MalfunctionNov 2, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SCOPE'S ELEVATOR PRODUCED A REFLECTION THAT MADE THE IMAGE QUALITY VERY POOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 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 18057441 ↗
• MalfunctionOct 31, 2023Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SCOPE'S ELEVATOR PRODUCED A REFLECTION THAT MADE THE IMAGE QUALITY VERY POOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041047 ↗
• MalfunctionAug 18, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, WHILE THE SCOPE WAS IN THE PATIENT'S ESOPHAGUS, THE IMAGE OF THE EXALT MODEL D SCOPE WAS LOST. THE SCOPE WAS UNPLUGGED AND RE-PLUGGED WITH NO RESULT. THEREFORE, A SECOND EXALT MODEL D SCOPE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572177 ↗
• MalfunctionFeb 16, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A SUSPECTED CHOLEDOCHOLITHIASIS ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN STARTED TO INTRODUCE A SPHINCTEROTOME DEVICE THROUGH THE WORKING CHANNEL OF THE EXALT MODEL D SCOPE. HOWEVER, IT WAS UNABLE TO PASS THE ACCESSORY DEVICE THROUGH THE WORKING CHANNEL. AS A RESULT, THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387239 ↗
• MalfunctionJan 23, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES ON (B)(6) 2022. WHEN THE PHYSICIAN STARTED THE ERCP PROCEDURE USING THE EXALT MODEL D SCOPE, THE MEDICAL STAFF IMMEDIATELY REALIZED THAT THE QUALITY OF THE PICTURE WAS NOT AS GOOD COMPARED TO PREVIOUS PROCEDURES. IT WAS REPORTED THAT THE IMAGE WAS BLURRY. THE ISSUE WAS NOTICED WHEN THE SCOPE WAS IN THE DUODENUM IN FRONT OF THE PAPILLA. THE CONNECTIONS WERE CHECKED, AND VALVES WERE CHANGED; HOWEVER, IT WAS NOT POSSIBLE TO GET A BETTER IMAGE QUALITY. ALTHOUGH PHYSICIAN TRIED TO CONTINUE THE ERCP PROCEDURE, HE DECIDED TO STOP THE PROCEDURE FOR THE PATIENT'S SAFETY. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223870 ↗
• MalfunctionDec 19, 2022Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED WITH THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2022-07476 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS INTRODUCED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2022. DURING THE PROCEDURE, THE PATIENT WAS PLACED UNDER LOCAL ANESTHESIA. THE SCOPE WAS INSERTED INTO THE PATIENT WHEN VISUALIZATION WAS LOST AND THE SCOPE ERROR SCREEN APPEARED. THE SCOPE WAS REMOVED FROM THE PATIENT AND A SECOND EXALT MODEL D SCOPE WAS INSERTED INTO THE PATIENT. VISUALIZATION WAS LOST INSIDE THE PATIENT AGAIN. THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005254 ↗
• MalfunctionDec 19, 2022Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS INTRODUCED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2022. DURING THE PROCEDURE, THE PATIENT WAS PLACED UNDER LOCAL ANESTHESIA. THE SCOPE WAS INSERTED INTO THE PATIENT WHEN VISUALIZATION WAS LOST AND THE SCOPE ERROR SCREEN APPEARED. THE SCOPE WAS REMOVED FROM THE PATIENT AND A SECOND EXALT MODEL D SCOPE WAS INSERTED INTO THE PATIENT. VISUALIZATION WAS LOST INSIDE THE PATIENT AGAIN. THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED WITH THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2022-07484 FOR THE ASSOCIATED DEVICE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005027 ↗
• MalfunctionDec 6, 2022Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE WHEN THE EXALT MODEL D SCOPE WAS IN THE ESOPHAGUS THE VISUALIZATION WAS LOST. THE EXALT SCOPE WAS UNPLUGGED AND PLUGGED BACK; HOWEVER, THE IMAGE WAS UNABLE TO BE RECOVERED. THE SCOPE WAS THEN REMOVED FROM THE PATIENT WITH NO VISUALIZATION. ANOTHER EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926849 ↗
• DeathNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON A 41-YEAR-OLD FEMALE PATIENT (B)(6), ENROLLED IN THE E7156 EXALT D SCOPE 02 STUDY, ON (B)(6) 2022. THE PATIENT WAS REFERRED FOR ERCP FOR THE INDICATION OF OBSTRUCTIVE JAUNDICE. AN ABDOMINAL SONAR REVEALED CHOLEDOCHOLITHIASIS, AND AN ENLARGED GALLBLADDER CONTAINING GRAVEL. THE PATIENT HAD A PREVIOUS ERCP DONE IN 2013 BUT COULD NOT GIVE ACCURATE DETAILS OF THE FINDINGS. A PLASTIC STENT HAD BEEN INSERTED AT THAT TIME. HOWEVER, THE PATIENT DENIED THAT A CHOLECYSTECTOMY WAS ADVISED, AND THAT THE STENT SHOULD HAVE BEEN REMOVED WITHIN A FEW MONTHS. THE ERCP FINDINGS OF THAT EXAMINATION WERE NOT AVAILABLE. DURING THE PROCEDURE, IT WAS CONFIRMED THAT A BLOCKED STENT WAS STILL IN PLACE. MULTIPLE SMALL STONES AND GRAVEL WERE PRESENT IN THE COMMON BILE DUCT (CBD). EFFORTS TO REMOVE THE STENT WITH BOTH THE EXALT SCOPE AND A REUSABLE SCOPE WERE UNSUCCESSFUL, INCLUDING THE USE OF A GRASPING FORCEPS. WHILE THE EXALT SCOPE WAS IN USE, A NON-BSC BALLOON WAS USED TO DILATE THE PAPILLA TO 12 MILLIMETERS AND THE PHYSICIAN EXPECTED THE STENT TO LOOSEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15798891 ↗
• MalfunctionOct 31, 2022Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (B)(6) 2022 FOR COLEDOCOLITIASIS. DURING THE PROCEDURE WITH EXALT MODEL D SCOPE, VISUALIZATION WAS LOST. THE EXALT SCOPE WAS UNPLUGGED AND PLUGGED BACK BUT THE IMAGE WAS UNABLE TO BE RECOVERED. ANOTHER EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700958 ↗