SpyGlass DS M00546650Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 08714729874348), received between Jan 15, 2020 and Sep 10, 2026 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (82 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716134 ↗
• MalfunctionAug 14, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252027 ↗
• MalfunctionAug 13, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240133 ↗
• 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 25429704 ↗
• MalfunctionMar 23, 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 SPYGLASS DIGITAL CONTROLLER WAS USED WITH A SPYSCOPE DS II DURING A CHOLANGIOSCOPY FOR INTERDUCTAL CLEARANCE ON (B)(6) 2026, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, VISUALIZATION WAS LOST. ALTHOUGH SUFFICIENT STONE CLEARANCE WAS ACHIEVED, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT AND THE PATIENT WAS RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662991 ↗
• MalfunctionMar 20, 2026Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES WERE USED IN THIS EVENT, THREE SPYSCOPE DS II AND ONE SPYGLASS DS CONTROLLER. THIS RECORD REPRESENTS SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER AND THREE SPYSCOPE DS II WERE ATTEMPTED FOR USE IN THE BILE DUCT DURING A CHOLANGIOSCOPE PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, NO IMAGING WAS OBTAINED, AND THREE DIFFERENT CATHETERS WERE ATTEMPTED. 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 24649147 ↗
• MalfunctionMar 13, 2026Fitting Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS II WERE ATTEMPTED FOR USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SURGICAL TEAM ATTEMPTED TO CONNECT THE SPYSCOPE TO THE CONSOLE AND IT WAS NOT RECOGNIZED. IT WAS INDICATED THAT THERE WAS DIFFICULTY PLUGGING IN THE SCOPE. TROUBLESHOOTING TASKS INCLUDED SWITCHING OFF THE ENTIRE SYSTEM AND UNPLUGGING THE SCOPE BEFORE RETRYING. THE PROBLEM DID NOT RESOLVE. ANOTHER SPYSCOPE WAS ATTEMPTED FOR USE HOWEVER, THE RESULT WAS THE SAME. THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. BOTH SCOPES WERE TESTED WITH A SECOND CONTROLLER FOLLOWING THE PROCEDURE, BOTH SCOPES FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597380 ↗
• MalfunctionFeb 4, 2026Poor Quality Image; Fitting Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER WAS ATTEMPTED FOR USE DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY STRICTURE. DURING THE PROCEDURE, THE SPYSCOPE DS CONTROLLER DID NOT DISPLAY AN IMAGE ON THE MONITOR. AFTER INSPECTION, IT APPEARED THAT THERE WAS NOT A PROPER CONNECTION AT THE PORT WHERE THE CATHETER IS CONNECTED TO THE CONTROLLER. THE PHYSICIAN WAS UNABLE TO COMPLETE THE ERCP 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 24259765 ↗
• MalfunctionFeb 3, 2026Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO THE SPY DS CONTROLLER USED TOGETHER WITH THE TWO SPYSCOPE DS II DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER AND THE TWO SPYSCOPE DS II WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPYSCOPE DS II DID NOT DISPLAY AN IMAGE. A SECOND SPYSCOPE DS II WAS THEN USED, BUT THE IMAGE STILL FAILED TO APPEAR. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. *ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026* THE CHOLANGIOSCOPY PROCEDURE TOOK PLACE ON (B)(6) 2026. BOTH SCOPES WERE TESTED WITH ANOTHER SPY DS CONTROLLER AND FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247296 ↗
• MalfunctionNov 24, 2025Connection Problem; Connection Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF 2 DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06263 FOR THE FIRST DEVICE, SPY DS CONTROLLER, AND 3005099803-2025-06270 FOR THE FOR THE SECOND DEVICE, SPYSCOPE DS II. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYSCOPE DS CONTROLLER WAS USED WITH A SPYSCOPE DS II IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, BEFORE THE SCOPE WAS INSERTED IN THE PATIENT, THE SPY DS CONTROLLER WAS REPORTED TO NOT BE WORKING PROPERLY. THE CONTROLLER POWERED UP, BUT THE LAMP WOULD NOT TURN ON. THE SPYSCOPE DS II COULD NOT BE USED DUE TO LACK OF VISUALIZATION. FURTHER TROUBLESHOOTING DETERMINED THAT THERE WAS A FAULTY VIDEO CABLE. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. DOUBLE PIGTAIL STENTS WERE PLACED UNTIL PATIENT CAN BE RESCHEDULED FOR AN ERCP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638255 ↗
• MalfunctionOct 28, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05538 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-05539 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF STONES ON (B)(6) 2025. THE IMAGE OF THE SPYSCOPE DS II WAS LOST APPROXIMATELY FIVE MINUTES INTO THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WILL BE RESCHEDULED ON (B)(6) 2025. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE WAS NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405549 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05358 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-05359 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF STONES ON (B)(6) 2025. DURING THE PROCEDURE, THE VISUALIZATION OF THE SPYSCOPE DS II WAS COMPROMISED DUE TO SCREEN LAG. THE MONITOR INTERMITTENTLY SWITCHED BETWEEN A LOADING SCREEN AND THE SPYGLASS LOGO, RESULTING IN LOSS OF IMAGE. THE PROCEDURE WAS NOT COMPLETED SUE TO THIS EVENT AND WILL BE RESCHEDULED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292511 ↗
• MalfunctionJul 21, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DS CONTROLLER WAS ATTEMPTED FOR USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) AND SPYGLASS PROCEDURE FOR THE TREATMENT OF BILIARY OBSTRUCTION ON (B)(6) 2025. IT WAS REPORTED THAT THE CONTROLLER WOULD NOT POWER ON. 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 22553956 ↗
• MalfunctionJul 3, 2025Poor Quality Image; Connection Problem; Poor Quality Image; Connection Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-03117 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-03118 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF MIGRATED STENT IN THE BILE DUCT ON (B)(6) 2025. DURING THE PROCEDURE, THE SPYSCOPE DS II HAD A BLACK AND WHITE IMAGE. THE SPYSCOPE DS II WAS UNPLUGGED AND RE-PLUGGED BACK INTO THE SPY DS CONTROLLER, RESTARTED THE CONTROLLER AND RE-PLUGGING THE VIDEO CABLES; HOWEVER, THE SAME PROBLEM OCCURRED. REPORTEDLY, THEY SWITCHED TO A NEW S-VIDEO CABLE AND CONFIRMED THAT THE VIDEO CABLE SUPPLIED BY BOSTON SCIENTIFIC WAS THE PROBLEM. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT AND WILL BE RESCHEDULED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395419 ↗
• MalfunctionJun 17, 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: 3005099803-2025-02681 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND 3005099803-2025-02683 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE ERCP WITH POC AND EHL, THE SPYGLASS DS DIRECT VISUALIZATION SYSTEM MALFUNCTIONED. ATTEMPTS TO CONNECT THE SPYSCOPE TO THE SYSTEM WERE UNSUCCESSFUL, AS THE LIGHT SOURCE FAILED TO ACTIVATE. DESPITE CHECKING CONNECTIONS AND REBOOTING THE SYSTEM, THE ISSUE PERSISTED, PREVENTING THE PROCEDURE FROM PROCEEDING. 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 22229397 ↗
• MalfunctionOct 3, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER WAS PREPARED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES IN THE BILE DUCT ON (B)(6) 2024. DURING SET UP FOR THE PROCEDURE, THE LIGHT SOURCE AND SYSTEM FAILED TO TURN ON. REPORTEDLY, THE MOVEMENT OF THE MALE CONNECTOR OF THE SCOPES UMBILICUS TEMPORARILY RESTORES FUNCTIONALITY, INDICATING A LIKELY LOOSE CONNECTION IN THE CONTROLLERS FEMALE CONNECTOR. 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 20358539 ↗
• MalfunctionSep 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DS CONTROLLER WAS PREPARED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT FOR THE TREATMENT OF BILE DUCT STONE REMOVAL ON (B)(6) 2024. IT WAS REPORTED THAT, PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE HOOKUP CONNECTION WITH SPYSCOPE DS II WAS WORN OUT. 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 20305486 ↗
• MalfunctionSep 25, 2024Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04619 FOR THE FIRST SPYSCOPE DS II ACCESS & DELIVERY CATHETER, 3005099803-2024-04620 FOR THE SECOND SPYSCOPE DS II ACCESS & DELIVERY CATHETER, AND 3005099803-2024-04785 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETERS WERE USED WITH A SPY DS CONTROLLER IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF COMMON BILE DUCT STONES ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO USE THE SPYGLASS, THE CATHETER DID NOT SHOW ANY LIGHTS WHEN PLUGGED INTO THE CONTROLLER. REPORTEDLY, THEY OPENED A SECOND SPYGLASS. HOWEVER, THE SECOND CATHETER DID NOT WORK EITHER. THE PHYSICIAN PLACED A PLASTIC STENT, AND 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 20304204 ↗
• MalfunctionJul 17, 2024Poor Quality Image; Device-Device Incompatibility; Optical Problem; Poor Quality Image; Device-Device Incompatibility; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO SPYSCOPE DS II DEVICES WERE USED WITH A SPY CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLANGIOSCOPY PROCEDURE IN BILIARY FOR THE TREATMENT OF BILIARY STONES ON (B)(6) 2024. THE FIRST SPYSCOPE WAS INSERTED INTO THE CONTROLLER DURING PREPARATION FOR THE PROCEDURE. THE INITIALIZATION SCREEN APPEARED AND THERE WAS NO VISUALIZATION. THE PHYSICIAN THEN SWITCHED TO A SECOND SPYSCOPE TO BEGIN THE PROCEDURE. THE SCOPE WAS INSERTED WITH SOME DIFFICULTY INTO THE BILE DUCT. THE PHYSICIAN STARTED USING THE ELECTROHYDRAULIC LITHOTRIPSY PROBE THROUGH THE SPYSCOPE TO TREAT THE BILIARY STONES. AFTER A FEW MINUTES, THE IMAGE WAS LOST AND COULD NOT BE REGAINED. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT AND WILL BE RESCHEDULED FOR 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 19764489 ↗
• MalfunctionJun 12, 2024Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER FOR THE SPY DS CONTROLLER, 3005099803-2024-02822 FOR THE FIRST SPYSCOPE, AND 3005099803-2024-02823 FOR THE SECOND SPYSCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETERS AND A SPY DS CONTROLLER WERE ATTEMPTED FOR USE IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF HILAR STENOSIS ON (B)(6) 2024. DURING PREPARATION FOR THE PROCEDURE, THERE WAS DIFFICULTY PLUGGING THE SPYSCOPE UMBILICUS CONNECTOR INTO THE CONTROLLER. THEY MADE TWO UNSUCCESSFUL ATTEMPTS WITH TWO DIFFERENT SPYSCOPES. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. IT WAS RESCHEDULED AND COMPLETED USING ANOTHER SPY DS CONTROLLER AND SPYSCOPE ON (B)(6) 2024. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519954 ↗
• MalfunctionJun 7, 2024Poor Quality Image; Connection Problem; Optical Problem; Poor Quality Image; Connection Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE SPY DS CONTROLLER WAS USED DURING SPYGLASS AND LITHOTRIPSY PROCEDURE FOR THE TREATMENT OF BILE DUCT STONES PERFORMED ON (B)(6) 2024. IT WAS REPORTED THERE WAS A LOOSE CONNECTION WHEN THE SPYSCOPE WAS CONNECTED TO THE CONTROLLER WHICH LED TO VIOLET AND GREEN GLITCHES WHILE DOING THE PROCEDURE, AND GRADUALLY SPYGLASS VISION WAS LOST. 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 19491544 ↗
• MalfunctionJun 7, 2024Device-Device Incompatibility; Optical Problem; Device-Device Incompatibility; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-02574 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER, AND 3005099803-2024-02697 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED WITH A SPY DS CONTROLLER IN THE LEFT HEPATIC DUCT TO MIDDLE BILE DUCT DURING A BILIARY LITHOTRIPSY PROCEDURES PERFORMED FOR THE TREATMENT OF BILE DUCT STONES ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS INSERTED THROUGH THE HGS ROUTE AND EHL WAS PERFORMED AT THE TARGET SITE, HOWEVER, THE DISPLAY ON THE SCREEN SUDDENLY DISAPPEARED, MAKING IT DIFFICULT TO CONTINUE THE PROCEDURE. 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 19486432 ↗
• MalfunctionJun 3, 2024Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DS CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) ON (B)(6) 2024. IT WAS REPORTED THERE WAS A TROUBLE IN USING THE SPYGLASS CONTROLLER DESPITE USING NEW SPYSCOPE . 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 19449858 ↗
• MalfunctionMay 17, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-02344 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND 3005099803-2024-02308 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DSII AND SPY DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY WITH LITHOTRIPSY PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT CHOLEDOCHOLITHIASIS ON (B)(6) 2024. IT WAS REPORTED THAT VISUALIZATION WAS LOST FIVE MINUTES INTO THE PROCEDURE. THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE. IT WAS RESCHEDULED AND COMPLETED 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 19340082 ↗
• MalfunctionMay 2, 2024Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-02050 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND 3005099803-2024-02049 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY PROCEDURES PERFORMED FOR THE TREATMENT OF BILIARY STONES IN THE BILIARY DUCT ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II DID NOT PROVIDE AN IMAGE. THE SPY DS CONTROLLER WAS DISCONNECTED AND RECONNECTED; TURNED OFF AND ON A FEW TIMES WITHOUT SUCCESS. 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 19229295 ↗