BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 24597380 · Received March 13, 2026

    Report

    Report Number
    3005099803-2026-00945
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729874348
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. D2B: SUBSEQUENT PRO CODES KQM NTN. INVESTIGATION RESULT SUMMARY THE SPY DS CONTROLLER WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED. THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED AND THE REPORTED EVENTS OF DEVICE CONNECTION ISSUE AND CANCELLED/RESCHEDULED POST SEDATION/SEDATION UNKNOWN COULD NOT BE CONFIRMED. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE IFU. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF DEVICE CONNECTION ISSUE AND CANCELLED/RESCHEDULED POST SEDATION/SEDATION UNKNOWN WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED AS THE MOST PROBABLE CAUSE OF THE CANCELLED PROCEDURE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. THE PROBABLE CAUSE OF THE DEVICE CONNECTION ISSUE HAS BEEN ASSIGNED THE CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM SINCE THE INVESTIGATION FINDINGS CANNOT CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, AND THE DEVICE WAS NOT RECEIVED FOR EVALUATION.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653692 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 1609700002 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown