BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS

    MDR report key: 25032179 · Received April 29, 2026

    Report

    Report Number
    3005099803-2026-01568
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    July 1, 2018
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF JULY 1, 2018, IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4: DETAILED MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: RADHIKA CHAVAN, ET AL. (2023). EFFICACY AND SAFETY OF DIGITAL SINGLE OPERATOR CHOLANGIOSCOPY GUIDED LASER LITHOTRIPSY FOR REMNANT CYSTIC DUCT STONE. A SINGLE TERTIARY CARE CENTER EXPERIENCE. INDIAN JOURNAL OF GASTROENTEROLOGY (JULY - AUGUST 2024) 43(4):841 - 844. HTTPS://DOI.ORG/10.1007/S12664-023-01418-9. BLOCK H6: IMDRF CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING SPYSCOPE DS THROUGH AND ARTICLE TITLED: EFFICACY AND SAFETY OF DIGITAL SINGLE OPERATOR CHOLANGIOSCOPY GUIDED LASER LITHOTRIPSY FOR REMNANT CYSTIC DUCT STONE. A SINGLE TERTIARY CARE CENTER EXPERIENCE BY RADHIKA CHAVAN, ET AL. PER THE ARTICLE, BETWEEN JULY 2018 TILL DECEMBER 2022, 167 PATIENTS UNDERWENT DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY (DSOC) WITH LASER LITHOTRIPSY UTILIZING THE SPYSCOPE DS FOR VARIOUS INDICATIONS. THE FEASIBILITY AND EFFECTIVITIY OF CHOLANGIOSCOPY-GUIDED LASER LITHOTRIPSY IN REMNANT CYSTIC DUCT STONES WAS EVALUATED. ADVERSE EVENTS WERE SEEN IN THREE PATIENTS, MILD EVENTS IN TWO PATIENTS (CHOLANGITIS AND PANCREATITIS) AND MODERATELY SEVERE ACUTE PANCREATITIS IN ONE PATIENT. NO OTHER PATIENT COMPLICATIONS WERE REPORTED. PLEASE SEE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096542 SPYSCOPE DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention