BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS

    MDR report key: 24900765 · Received April 16, 2026

    Report

    Report Number
    3005099803-2026-01394
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    January 1, 2015
    Report Date
    April 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF JANUARY 1, 2015, IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: CLAUDIO C. CONRAD, ET AL. "LONG-TERM EFFICACY AND SAFETY OF DIGITAL-SINGLE-OPERATOR - VIDEO-PANCREATOSCOPY GUIDED LITHOTRIPSY FOR PANCREATIC DUCT STONES" UNITED EUROPEAN GASTROENTEROLOGY JOURNAL, 2025; 13:1127-1132. DOI: HTTPS://DOI.ORG/10.1002/UEG2.70063. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PANCREATITIS. IMDRF IMPACT CODE E1021 CAPTURES THE SERIOUS INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING SPYSCOPE DS THROUGH THE ARTICLE, "LONG-TERM EFFICACY AND SAFETY OF DIGITAL-SINGLE-OPERATOR VIDEO-PANCREATOSCOPY GUIDED LITHOTRIPSY FOR PANCREATIC DUCT STONES," BY CLAUDIO C. CONRAD, ET AL. THE ARTICLE DESCRIBES AN INTERNATIONAL RETROSPECTIVE STUDY BETWEEN 2015 AND 2022. THE STUDY INVOLVED 58 PATIENTS WHO UNDERWENT DSOVP - GUIDED LITHOTRIPSY WITH EHL USING SPYGLASS DS SYSTEM. ACCORDING TO THE ARTICLE, THE OVERALL ADVERSE EVENT RATE WAS 11 (26%) BASED ON AVAILABLE DATA FROM 41 PATIENTS. NINE PATIENTS (22%) DEVELOPED POST - ERCP PANCREATITIS (8 MILD, 1 MODERATE), REPRESENTING THE MOST FREQUENT ADVERSE EVENT, WHILE 2 PATIENTS (4.9%) HAD POST PROCEDURE FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963584 SPYSCOPE DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION UNK-P-SPYSCOPE_DS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other