SpyScope™ DS II M00546610Recalls & reported problems

Summary

The FDA's MAUDE database contains 646 adverse event reports that list this exact device (DI 08714729965404), received between Dec 17, 2018 and Sep 28, 2026 — classified as 2 deaths, 17 injuries, 627 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (563 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 646 reports, in the reporter's own words as published by the FDA.

• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a SpyGlass procedure with biopsy was performed on (b)(6) 2026 at approximately 9:00 AM at (b)(6). The procedure involved exploration of the bile ducts using one SpyScope and biopsy of the bile duct walls using one SpyBite Max. The procedure was requested by endoscopist Ana Alicia Rosales Solis and was performed in the outpatient procedure room without an Autolite console or probe.The physician initiated the ERCP using an Olympus duodenoscope and sphincterotome, with the assistance of two endoscopy technicians and one resident physician. After sphincterotomy, the SpyScope was prepared by flushing the working and irrigation channels with saline and connecting the irrigation channel to a water pump. The SpyGlass console and illumination were activated, and video recording was confirmed.The bile ducts were successfully examined with the SpyScope, and no bleeding was observed. The physician then requested the SpyBite Max to obtain biopsies of the bile duct walls. The biopsies were completed without reported complications.After the final biopsy, the physician noticed that the patient had developed a blue discoloration and informed the

  Patient problems: Respiratory Failure

  MAUDE report 50923454 ↗
• MalfunctionAug 19, 2026Optical Problem

  It was reported to Boston Scientific Corporation that a SpyScope DS II was intended for use during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure on (b)(6) 2026 to obtain diagnostic biopsies.During the procedure, the new SpyScope was connected, however, no image was displayed on the screen. Despite several troubleshooting attempts to re-establish the connection, the system did not function correctly. As a result, the procedure had to be abandoned and could not be completed.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334604 ↗
• MalfunctionAug 14, 2026Device-Device Incompatibility; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252023 ↗
• MalfunctionAug 13, 2026Poor Quality Image; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234759 ↗
• MalfunctionAug 11, 2026Poor Quality Image; Difficult to Advance; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216980 ↗
• MalfunctionAug 7, 2026Optical Problem

  It was reported to Boston Scientific Corporation that a SpyScope DS II device was intended for use during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure on (b)(6) 2026 for treatment of bile duct stones.During the procedure, the SpyScope was inserted into the controller and no image appeared. They tried replugging in the scope, but visualization could not be gained. The procedure could not be completed as a result of this event. The physician placed a stent, and the procedure will be rescheduled. No patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180731 ↗
• MalfunctionJul 16, 2026Adverse Event Without Identified Device or Use Problem; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849841 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II WERE ATTEMPTED FOR USE IN THE BILE DUCT FOR STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SECOND SCOPE WAS OPENED AFTER THE INITIAL SCOPE LOST VISUALIZATION. THE REPLACEMENT SCOPE PROVIDED CLEAR VISUALIZATION THROUGHOUT THE USE OF THE FIRST EHL PROBE AND FOR APPROXIMATELY THREE MINUTES DURING USE OF THE SECOND EHL PROBE BEFORE VISUALIZATION WAS AGAIN LOST AND FIVE GRAY DOTS APPEARED ON THE SCREEN. REPORTEDLY, BOTH PROBES WERE OPERATED ON LOW POWER WITH FIVE PULSES. MULTIPLE ATTEMPTS WERE MADE TO RESTORE VISUALIZATION BY UNPLUGGING THE SCOPE AND RESTARTING THE PROCESSOR. HOWEVER, VISUALIZATION COULD NOT BE REGAINED. AS A RESULT OF THIS EVENT, THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE AND PLACE TWO DOUBLE PIGTAIL STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536452 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II WERE ATTEMPTED FOR USE IN THE BILE DUCT FOR STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SECOND SCOPE WAS OPENED AFTER THE INITIAL SCOPE LOST VISUALIZATION. THE REPLACEMENT SCOPE PROVIDED CLEAR VISUALIZATION THROUGHOUT THE USE OF THE FIRST EHL PROBE AND FOR APPROXIMATELY THREE MINUTES DURING USE OF THE SECOND EHL PROBE BEFORE VISUALIZATION WAS AGAIN LOST AND FIVE GRAY DOTS APPEARED ON THE SCREEN. REPORTEDLY, BOTH PROBES WERE OPERATED ON LOW POWER WITH FIVE PULSES. MULTIPLE ATTEMPTS WERE MADE TO RESTORE VISUALIZATION BY UNPLUGGING THE SCOPE AND RESTARTING THE PROCESSOR. HOWEVER, VISUALIZATION COULD NOT BE REGAINED. AS A RESULT OF THIS EVENT, THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE AND PLACE TWO DOUBLE PIGTAIL STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536388 ↗
• MalfunctionJun 9, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED IN THE DISTAL COMMON BILE DUCT FOR BIOPSY DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT FORCEPS COULD NOT BE ADVANCED THROUGH THE DISTAL TIP OF THE SPYSCOPE. THE PATH OF THE SCOPE WAS NOTED TO BE TORTUOUS. 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 25446857 ↗
• MalfunctionJun 9, 2026Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND SPY DS CONTROLLER WERE ATTEMPTED FOR USE IN THE COMMON BILE DUCT FOR STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE SPYGLASS WAS INTRODUCED INTO THE CBD, THE IMAGE BECAME HAZY AND UNCLEAR. SHORTLY THEREAFTER, THE DISPLAY STOPPED FUNCTIONING AND SEVERAL DOTS APPEARED ON THE SCREEN. WE ATTEMPTED TO RESET THE CONNECTIONS, BUT THE SAME ISSUE PERSISTED. AS A RESULT, THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446026 ↗
• MalfunctionJun 8, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DEVICE WAS INTENDED FOR USE WITH A SPY CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY HAD NORMAL VISUALIZATION. HOWEVER, AFTER SOME TIME, THE IMAGE WAS SUDDENLY LOST COMPLETELY. MULTIPLE ATTEMPTS WERE MADE TO RESTORE THE IMAGE BY DISCONNECTING AND RECONNECTING THE SYSTEM COMPONENTS; HOWEVER, THE ISSUE PERSISTED AND VISUALIZATION WAS NOT RECOVERED. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT, AND THE PATIENT WILL BE RESCHEDULED FOR A REPEAT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430725 ↗
• MalfunctionMay 19, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE BILE DUCT ON (B)(6) 2026, FOR THE TREATMENT OF BILE DUCT STONES. DURING THE PROCEDURE, AFTER SUCCESSFULLY CRUSHING ONE STONE, THE SPYSCOPE WAS TEMPORARILY REMOVED FROM THE ENDOSCOPE WORKING CHANNEL IN ORDER TO SWEEP THE BILE DUCT. THE PLAN WAS THEN TO REINSERT THE SPYSCOPE THROUGH THE ENDOSCOPE INTO THE BILE DUCT TO CRUSH AN ADDITIONAL STONE. HOWEVER, IT WAS OBSERVED THAT THE SPYSCOPE NO LONGER PRODUCED AN IMAGE ON THE MONITOR, AS VISUALIZATION WAS LOST AT SOME POINT DURING THE PROCEDURE. BY MANIPULATING THE SPYSCOPE, BOTH IMAGE AND LIGHT WERE BRIEFLY RESTORED; HOWEVER, THE IMAGE REMAINED INTERMITTENT AND DISTORTED. AS A RESULT, THE PROCEDURE WAS CANCELED, AND THE PATIENT WILL BE RESCHEDULED FOR A REPEAT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224971 ↗
• MalfunctionApr 30, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS USED DURING A CHOLANGIOSCOPY-GUIDED LITHOTRIPSY PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF A COMMON BILE DUCT STONE. DURING THE PROCEDURE, VISUALIZATION WAS LOST APPROXIMATELY 10 MINUTES AFTER THE SCOPE WAS IN USE. TROUBLESHOOTING WAS PERFORMED, INCLUDING POWERING OFF THE CONTROLLER AND RESTARTING IT; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS CANCELED, AND THE PATIENT WILL BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048836 ↗
• MalfunctionApr 30, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS USED DURING A CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF A STRICTURE. DURING THE PROCEDURE, APPROXIMATELY 15 MINUTES AFTER THE SCOPE WAS IN USE, VISUALIZATION WAS LOST. TROUBLESHOOTING WAS ATTEMPTED, INCLUDING TURNING OFF THE CONTROLLER AND RESTARTING IT; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS CANCELED, AND THE PATIENT WILL BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046210 ↗
• MalfunctionApr 29, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II ACCESS AND DELIVERY CATHETERS WERE ATTEMPTED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF STRICTURE. DURING THE PROCEDURE, THE SPYSCOPE HAD LOSS OF VISUALIZATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033857 ↗
• MalfunctionApr 29, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II ACCESS AND DELIVERY CATHETERS WERE ATTEMPTED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF STRICTURE. DURING THE PROCEDURE, THE SPYSCOPE HAD LOSS OF VISUALIZATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033799 ↗
• MalfunctionApr 28, 2026Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS ATTEMPTED FOR USE DURING A CHOLANGIOSCOPY WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY COLLECTION. DURING THE PROCEDURE, THE FIRST SPYSCOPE LOST VISUALIZATION. A SECOND WAS OPENED, BUT IT ALSO LOST VISUALIZATION. TROUBLESHOOTING WAS ATTEMPTED WITHOUT SUCCESS, AND DESPITE THE EFFORTS, THE PROCEDURE WAS CANCELED AND THE PATIENT WILL BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022715 ↗
• MalfunctionApr 28, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS ATTEMPTED FOR USE DURING A CHOLANGIOSCOPY WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY COLLECTION. DURING THE PROCEDURE, THE FIRST SPYSCOPE LOST VISUALIZATION. A SECOND WAS OPENED, BUT IT ALSO LOST VISUALIZATION. TROUBLESHOOTING WAS ATTEMPTED WITHOUT SUCCESS, AND DESPITE THE EFFORTS, THE PROCEDURE WAS CANCELED AND THE PATIENT WILL BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021715 ↗
• MalfunctionApr 14, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS ATTEMPTED FOR USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILE DUCT TUMOR. DURING THE PROCEDURE, THE SPYBITE BIOPSY FORCEPS ARE UNABLE TO PASS THROUGH THE WORKING CHANNEL OF THE SPYGLASS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876137 ↗
• MalfunctionApr 10, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS INTENDED FOR USE DURING A CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2026 FOR THE TREATMENT OF A STONE IN THE HEPATIC DUCT. UPON CONNECTING THE SPYSCOPE AND PROCEEDING WITH THE PROCEDURE, THE IMAGE WAS LOST. ATTEMPTS WERE MADE TO RECONNECT AND ADJUST THE DEVICE; HOWEVER, THE ISSUE PERSISTED. THE DEVICE WAS REMOVED, RESULTING IN LOSS OF POSITIONING, AND A NEW SPYSCOPE WAS OPENED. THE SAME ISSUE OCCURRED WITH THE SECOND SCOPE. AS THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845812 ↗
• MalfunctionApr 10, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS INTENDED FOR USE DURING A CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2026 FOR THE TREATMENT OF A STONE IN THE HEPATIC DUCT. UPON CONNECTING THE SPYSCOPE AND PROCEEDING WITH THE PROCEDURE, THE IMAGE WAS LOST. ATTEMPTS WERE MADE TO RECONNECT AND ADJUST THE DEVICE; HOWEVER, THE ISSUE PERSISTED. THE DEVICE WAS REMOVED, RESULTING IN LOSS OF POSITIONING, AND A NEW SPYSCOPE WAS OPENED. THE SAME ISSUE OCCURRED WITH THE SECOND SCOPE. AS THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845681 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS INTENDED FOR USE DURING A BILIARY DUCT OBSERVATION PROCEDURE ON (B)(6) 2026, IN THE BILIARY TRACT. IT WAS REPORTED THAT THE IMAGE DISAPPEARED DURING THE PROCEDURE. ATTEMPTS WERE MADE TO RECONNECT THE SPYSCOPE TO THE CONTROLLER; HOWEVER, DESPITE THESE EFFORTS, THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834969 ↗
• MalfunctionApr 8, 2026Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE IMAGE OF THE SPYSCOPE DS II WAS NOT DISPLAYED AFTER THE SPY DS CONTROLLER LIGHT WAS TURNED OFF. THE DEVICE WAS PLUGGED IN AND OUT, BUT THE LIGHT CONTINUED TO FLASH CONTINUOUSLY, EVENTUALLY RENDERING IT UNUSABLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818364 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II DEVICE WAS ATTEMPTED FOR USE DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, THE SCOPE LOST VISUALIZATION WHILE USING ELECTROHYDRAULIC LITHOTRIPSY (EHL). TROUBLESHOOTING STEPS WERE ATTEMPTED TO RESOLVE THE ISSUE, INCLUDING UNPLUGGING AND REPLUGGING THE SCOPE IN. A BALLOON SWEEP WAS THEN ATTEMPTED BUT WAS UNSUCCESSFUL AT REMOVING THE STONE. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO THIS EVENT. A STENT WAS PLACE AND THE PATIENT WILL BE RESCHEDULED FOR ANOTHER ERCP NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24733149 ↗