SpyGlass™ Discover M00546780Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08714729994183), received between Sep 10, 2020 and Sep 24, 2026 — classified as 1 death, 7 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (41 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that a Spy Discover Catheter was utilized in a LCBDE (laparoscopic common bile duct exploration) procedure on (b)(6) 2026 for treatment of stones in the common bile duct.During the procedure, a piece of the light blue covering at the distal end of the SpyGlass Discover catheter had chipped off into the patient abdomen. The physician performed an an exploratory laparotomy for small bowel resection however was not able to locate the piece that chipped off. Patient is scheduled for a follow up visit. Procedure was completed with the original device. No other patient complications were reported as a result of the event.

  Patient problems: Foreign Body In Patient

  MAUDE report 50882077 ↗
• MalfunctionAug 3, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115120 ↗
• MalfunctionJun 30, 2026Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS? DISCOVER WAS USED IN THE LARGE COMMON BILE DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE FOR THE TREATMENT OF BILIARY STONE MANAGEMENT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE ATTEMPTING TO ACCESS THE CYSTIC DUCT, VISUALIZATION ABRUPTLY DISPLAYED THREE FIXED POINTS ON THE SCREEN, FOLLOWED BY A COMPLETE LOSS OF IMAGE. THE DEVICE CEASED FUNCTIONING IMMEDIATELY AFTER THIS VISUAL DISTURBANCE. THE PROBLEM OCCURRED DURING ACTIVE USE OF THE ACCESSORY, WITH CONTINUOUS IRRIGATION MAINTAINED THROUGHOUT THE PROCEDURE. NO ABNORMALITIES HAD BEEN OBSERVED PRIOR TO THIS EVENT. 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 25665623 ↗
• MalfunctionJun 26, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS USED DURING A DISCOVER AND AUTOLITH PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, AFTER APPROXIMATELY 2 HOURS AND 30 MINUTES, THE DEVICE WAS REMOVED FROM ONE DRAIN AND INSERTED INTO ANOTHER DRAIN. AT THAT TIME, VISUALIZATION WAS LOST DURING DUCT INSPECTION, AND THE IMAGE COULD NOT BE RESTORED. TROUBLESHOOTING WAS PERFORMED, INCLUDING RESTARTING THE SYSTEM, DISCONNECTING AND RECONNECTING THE DEVICE, AND ATTEMPTING TO OPTIMIZE THE SETUP. HOWEVER, THESE EFFORTS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT 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 25644106 ↗
• MalfunctionJun 8, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER WAS UTILIZED DURING A COMMON BILE DUCT EXPLORATION (CBDE) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. THE SCOPE VISUALIZATION WAS LOST DURING THE COMMON BILE DUCT EXPLORATION (CBDE) PORTION OF THE PROCEDURE. THE STAFF ATTEMPTED TO UN-PLUG AND RE-PLUG MULTIPLE TIMES, AND THE SCOPE STILL DID NOT WORK. THE PHYSICIAN ELECTED TO COMPLETE PROCEDURE WITHOUT COMMON BILE DUCT EXPLORATION (CBDE). COMMON BILE DUCT EXPLORATION (CBDE) PORTION OF THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT, AND AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435627 ↗
• MalfunctionJun 1, 2026Poor Quality Image; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYSCOPE WAS UTILIZED IN A COMMON BILE DUCT EXPLORATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE SCOPE WAS PLUGGED IN AND THERE WERE NO ISSUES WERE PRESENT AT FIRST. AFTER A FEW MINUTES THE LIGHTING THE SCOPE MADE IT DIFFICULT TO SEE ANYTHING. THE STAFF PLUGGED THE SCOPE OUT AND BACK IN TO SEE IF THAT CHANGED ANYTHING AND ADJUSTED LIGHTING ON THE CONTROLLER WITH NO SUCCESS. PHYSICIAN WAS UNABLE TO COMPLETE SUCCESSFUL CBDE DUE TO THAT BEING THE ONLY SCOPE AVAILABLE. THE PATIENT HAD TO UNDERGO A CHOLANGIOGRAPHY WITH POST OPERATIVE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352718 ↗
• MalfunctionMay 7, 2026Optical Problem

  IT WAS REPORTED THAT A SPY DISCOVER CATHETER WAS USED DURING IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPY DISCOVER PROCEDURE ON (B)(6) 2026 FOR CANCER MONITORING. IN PREPARATION TO THE PROCEDURE, THE PHYSICIAN WENT IN PERCUTANEOUSLY AND ADVANCED A WIRE. WHEN THE PHYSICIAN REQUESTED THE SPY DISCOVER, IT WAS CONNECTED TO THE CONTROLLER, AND THE LIGHT SOURCE WOULD NOT TURN ON. DESPITE TROUBLESHOOTING EFFORTS, SCOPE VISUALIZATION COULD NOT BE GAINED. AS THERE WAS NO BACKUP EQUIPMENT AVAILABLE, THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS RESCHEDULED AND COMPLETED SUCCESSFULLY ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113797 ↗
• MalfunctionMay 7, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER WAS ATTEMPTED FOR USE IN THE COMMON BILE DUCT DURING A COMMON BILE DUCT EXPLORATION PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY OBSTRUCTION. DURING THE PROCEDURE, THE SCOPE STOPPED WORKING IN THE MIDDLE OF THE CASE AND GRAY DOTS APPEARED ON THE SCREEN. 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 25112256 ↗
• MalfunctionApr 28, 2026Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYGLASS DISCOVERER CATHETER WAS UTILIZED IN A BILIARY STONE REMOVAL PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE A BASKET AND LITHOTRIPSY WERE UTILIZED FOR ABOUT THREE HOURS WITH AN IRRIGATION PUMP. THE SCREEN ON THE SPYGLASS DISCOVERER CATHETER BEGAN TO FLICKER, AND THE VIDEO OUTPUT SLOWED SIGNIFICANTLY. DUE TO THESE TECHNICAL ISSUES, THE SCOPE EVENTUALLY STOPPED FUNCTIONING AS INTENDED, MAKING IT IMPOSSIBLE TO COMPLETE THE PROCEDURE AS PLANNED. AS A RESULT, THE PHYSICIAN MADE THE DECISION TO END THE PROCEDURE PREMATURELY AND RESCHEDULE THE TREATMENT FOR A LATER DATE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021550 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED FOR THE TREATMENT OF GALLSTONES IN THE GALLBLADDER DURING A PERCUTANEOUS CHOLECYSTOSTOMY (PCC) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SCOPE FUNCTIONED WELL FOR APPROXIMATELY 20 TO 30 MINUTES WHILE USING THE ERBE IRRIGATION PUMP, AFTER WHICH THE IMAGE WAS LOST AGAIN. AT THAT TIME, THE EHL WAS IN USE, BUT THE ISSUE OCCURRED SIMILARLY TO THE PREVIOUS SCOPE. AFTER A DELAY OF APPROXIMATELY 20 MINUTES, THE PROCEDURE WAS DISCONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834985 ↗
• MalfunctionApr 6, 2026Material Integrity Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYGLASS DISCOVER DIGITAL CATHETERS WERE USED FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS IN THE COMMON BILE DUCT DURING A CHOLECYSTECTOMY AND LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SPYGLASS LIGHT SOURCE WAS CONNECTED TO A STRYKER SECONDARY MONITOR. WHEN THE PHYSICIAN ATTEMPTED TO BEGIN SCOPING, NO VISUALIZATION WAS OBSERVED ON THE MONITOR. MULTIPLE DVI CABLES AND MONITORS WERE EXCHANGED WITHOUT RESTORING IMAGE DISPLAY. A SECOND SPYGLASS DISCOVER CATHETER WAS OPENED; HOWEVER, VISUALIZATION REMAINED ABSENT. BOTH SPYGLASS DISCOVER CATHETERS EXHIBITED A YELLOW GLOW AT THE CONNECTOR INTERFACE WHEN PLUGGED INTO THE LIGHT SOURCE. DUE TO THE INABILITY TO OBTAIN VISUALIZATION, THE CLINICAL TEAM WAS UNABLE TO COMPLETE THE CBD EXPLORATION. THE PATIENT WAS SUBSEQUENTLY REFERRED FOR A POST-OPERATIVE ERCP. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793880 ↗
• MalfunctionApr 6, 2026Material Integrity Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYGLASS DISCOVER DIGITAL CATHETERS WERE USED FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS IN THE COMMON BILE DUCT DURING A CHOLECYSTECTOMY AND LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SPYGLASS LIGHT SOURCE WAS CONNECTED TO A STRYKER SECONDARY MONITOR. WHEN THE PHYSICIAN ATTEMPTED TO BEGIN SCOPING, NO VISUALIZATION WAS OBSERVED ON THE MONITOR. MULTIPLE DVI CABLES AND MONITORS WERE EXCHANGED WITHOUT RESTORING IMAGE DISPLAY. A SECOND SPYGLASS DISCOVER CATHETER WAS OPENED; HOWEVER, VISUALIZATION REMAINED ABSENT. BOTH SPYGLASS DISCOVER CATHETERS EXHIBITED A YELLOW GLOW AT THE CONNECTOR INTERFACE WHEN PLUGGED INTO THE LIGHT SOURCE. DUE TO THE INABILITY TO OBTAIN VISUALIZATION, THE CLINICAL TEAM WAS UNABLE TO COMPLETE THE CBD EXPLORATION. THE PATIENT WAS SUBSEQUENTLY REFERRED FOR A POST-OPERATIVE ERCP. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793854 ↗
• MalfunctionMar 4, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DEVICE WAS ATTEMPTED FOR USE DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, THE SCOPE LOST VISUALIZATION. TROUBLESHOOTING STEPS WERE PERFORMED TO RESOLVE THE ISSUE, INCLUDING UNPLUGGING AND RECONNECTING ALL CONNECTIONS, RESTARTING THE CONTROLLER, AND CLEANING THE SCOPE. DESPITE THESE EFFORTS, THE PHYSICIAN WAS UNABLE TO COMPLETE THE CHOLECYSTECTOMY DUE TO THIS EVENT. THE PATIENT WAS SENT FOR A POST OPERATIVE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR TREATMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513624 ↗
• MalfunctionMar 3, 2026

  SPYGLASS DISCOVER DIGITAL CATHETER THE SCREEN WENT BLACK IN THE MIDDLE OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495418 ↗
• MalfunctionJan 26, 2026Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO SPY DISCOVER CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPY DISCOVER CATHETERS WERE ATTEMPTED FOR USE IN THE CYSTIC DUCT WITH COMMON BILE DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, THE VISUALIZATION FLICKERED AND THEN CHANGED TO THE LOADING SCREEN APPROXIMATELY TEN MINUTES AFTER THE FLUIDICS PUMP WAS INTRODUCED FOR IRRIGATION. ATTEMPTS TO RESTORE VISUALIZATION BY UNPLUGGING AND RECONNECTING THE DEVICE WERE UNSUCCESSFUL. THEY ATTEMPTED TO USE A SECOND SPY DISCOVER CATHETER, WHICH PRESENTED WITH THE SAME MALFUNCTION. A BALLOON SWEEP WAS THEN ATTEMPTED BUT FAILED TO REMOVE THE STONE. AFTER A DELAY OF APPROXIMATELY 30 MINUTES, THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS DISCONTINUED. THE PATIENT WAS THEN SENT INTERVENTIONAL RADIOLOGY (IR) FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184304 ↗
• MalfunctionJan 26, 2026Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO SPY DISCOVER CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPY DISCOVER CATHETERS WERE ATTEMPTED FOR USE IN THE CYSTIC DUCT WITH COMMON BILE DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, THE VISUALIZATION FLICKERED AND THEN CHANGED TO THE LOADING SCREEN APPROXIMATELY TEN MINUTES AFTER THE FLUIDICS PUMP WAS ACTIVATED FOR IRRIGATION. ATTEMPTS TO RESTORE VISUALIZATION BY UNPLUGGING AND RECONNECTING THE DEVICE WERE UNSUCCESSFUL. THEY ATTEMPTED TO USE A SECOND SPY DISCOVER CATHETER, WHICH PRESENTED WITH THE SAME MALFUNCTION. A BALLOON SWEEP WAS THEN ATTEMPTED BUT FAILED TO REMOVE THE STONE. AFTER A DELAY OF APPROXIMATELY 30 MINUTES, THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS DISCONTINUED. THE PATIENT WAS THEN SENT INTERVENTIONAL RADIOLOGY (IR) FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184297 ↗
• MalfunctionJan 13, 2026Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO SPYGLASS DISCOVER DIGITAL CATHETERS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED IN THE BILE DUCT DURING AN LCBDE (LAPAROSCOPIC COMMON BILE DUCT EXPLORATION) FOR CHOLEDOCHOLITHIASIS ON (B)(6) 2025. DURING THE PROCEDURE, VISUALIZATION SKIPPED IN AND OUT AND FINALLY TURNED OFF COMPLETELY. ATTEMPTS TO RESTORE VISUALIZATION BY UNPLUGGING AND RECONNECTING THE DEVICE WERE UNSUCCESSFUL. ANOTHER SPYGLASS WAS OPENED, AND THE SAME ISSUE OCCURRED. THE LCBDE PROCEDURE WAS NOT COMPLETED AS RESULT OF THIS EVENT. THE PATIENT WAS THEN SEEN AT ANOTHER FACILITY FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059482 ↗
• MalfunctionDec 30, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED IN BILE DUCT DURING A POST-LAPAROSCOPIC CHOLECYSTECTOMY BILE DUCT EXPLORATION (POST LAP CHOLE BDE) PROCEDURE PERFORMED FOR THE TREATMENT OF STONES ON (B)(6) 2025. PRIOR TO THE PROCEDURE, WHEN THE SPYGLASS DISCOVER DIGITAL CATHETER WAS CONNECTED TO THE CONTROLLER, ONLY THREE GREY CIRCLES AND NO IMAGE APPEARED ON THE SCREEN. ATTEMPTS TO HAVE VISUALIZATION BY UNPLUGGING AND RECONNECTING THE DEVICE WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS TRANSFERRED FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928229 ↗
• DeathDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER WAS USED DURING AN INTERVENTIONAL RADIOLOGY (IR) PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, AN IRRIGATION PUMP WAS CONNECTED TO THE IRRIGATION PORT OF THE SPY DISCOVER CATHETER. THE PROCEDURE LASTED APPROXIMATELY SEVEN TO EIGHT HOURS AND THE PHYSICIAN USED BETWEEN SIX AND TEN BOTTLES OF ONE THOUSAND MILLILITER (ML) STERILE WATER FOR IRRIGATION. THE PATIENT WAS CONFUSED UPON EXITING THE PROCEDURE AND SUBSEQUENTLY PASSED AWAY AT A LATER DATE. THERE WAS NO REPORTED ALLEGATION WITH THE SPY DISCOVER CATHETER. THE PATIENT'S CAUSE OF DEATH IS UNKNOWN AT THIS TIME, AND AN INVESTIGATION IS UNDER WAY AT (B)(6) HOSPITAL. IT WAS REPORTED THAT "MANY HAVE IMPLIED THAT HYPONATREMIA OCCURRED, BUT THEY ARE INVESTIGATING POTENTIAL OTHER FACTORS". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Confusion/ Disorientation; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 23887967 ↗
• MalfunctionAug 6, 2025Mechanical Problem; Activation, Positioning or Separation Problem

  SPYGLASS DISCOVER DIGITAL CATHETER STOPPED WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728166 ↗
• MalfunctionMar 26, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II WAS USED DURING A ROBOTIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION ON (B)(6) 2025. THERE WAS NO VISUALIZATION WHEN THE SCOPE WAS PLUGGED IN. 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 21696376 ↗
• MalfunctionOct 1, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04816 FOR THE SPYGLASS DISCOVER DIGITAL CATHETER AND 3005099803-2024-04818 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DISCOVER CATHETER AND SPY DS CONTROLLER WERE USED DURING LAPAROSCOPIC COMMON BILE DUCT EXPLORATION DURING CHOLECYSTECTOMY PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS ON (B)(6) 2024. IT WAS REPORTED THAT THE IMAGE WAS LOST, AND THEY DON' T HAVE ANOTHER SCOPE TO REMOVE THE STONES. 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 20346510 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER ALONG WITH ACCESSORIES WERE USED IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024. WHEN THE PATIENT HAD A CHOLECYSTECTOMY WITH AN INTRAOPERATIVE CHOLANGIOGRAM (IOC) IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) ON (B)(6) 2024. THE PHYSICIAN REPORTED THE PATIENT PRESENTED WITH BILE DUCT LEAK ON CT SCAN. ON (B)(6) 2024, THE PATIENT WAS SCHEDULED FOR AN ERCP FOLLOW UP FOR A MEDICAL INTERVENTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Biliary Leak; Insufficient Information

  MAUDE report 19601754 ↗
• MalfunctionMar 12, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DISCOVER CATHETER COMPLAINT WAS USED DURING PERCUTANEOUS CHOLANGIOSCOPY FOR THE TREATMENT OF GALLSTONES PERFORMED IN THE GALLBLADDER ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE SCOPE AND BASKET WERE USED TO REMOVE GALLSTONES FROM THE GALLBLADDER, THE 3 DOTS APPEARED ON THE SCREEN, AND THEY LOST VISUALIZATION FROM THE SCOPE. THE PROCEDURE WAS NOT COMPLETED AND RESCHEDULED ON (B)(6) 2024. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888500 ↗
• MalfunctionJan 30, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTES: THIS REPORT PERTAINS TO TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-00211 FOR THE SPY DISCOVER CATHETER AND 3005099803-2024-00210 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DISCOVER CATHETER AND SPY DS CONTROLLER WERE USED DURING A LITHOTRIPSY IN RADIOLOGICAL PROCEDURE PERFORMED IN THE HEPATIC DUCT FOR THE TREATMENT OF HEPATIC STONES ON (B)(6) 2024. DURING PROCEDURE, THE VISUALIZATION OF THE SPY DISCOVER CATHETER WAS LOST AFTER 30 MINUTES OF USAGE. THE SCOPE WAS CONNECTED AND DISCONNECTED TO THE SPY DS CONTROLLER SEVERAL TIMES HOWEVER, THE VISUALIZATION WAS LOST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE RESCHEDULED PROCEDURE IS PLANNED TO BE COMPLETED AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605538 ↗