BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    MDR report key: 20945474 · Received December 16, 2024

    Report

    Report Number
    1037905-2024-00812
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 16, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ODC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K213483. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL SNAPLOC WIRE GUIDE LOCKING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING SEPARATE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED THREE (3) COOK SNAPLOC WIRE GUIDE LOCKING DEVICES. IT WAS REPORTED THAT THE GUIDEWIRE PULLED OUT OF THE DUCT WHEN THE DEVICE WAS WITHDRAWN. IT WAS ESTABLISHED THAT THIS WAS OCCURRING DUE TO THE GUIDEWIRE NOT BEING HELD IN PLACE BY THE WIRE LOCK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381041 SNAPLOC WIRE GUIDE LOCKING DEVICE ODC ENDOSCOPE CHANNEL ACCESSORY ODC WILSON-COOK MEDICAL INC G59683 W4860069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0.35 OLYMPUS VISIGLIDE ANGLE TIP WIREGUIDE| BOSTON EXTRACTION BALLOON, MODEL UNKNOWN| OLYMPUS DUODENOSCOPE, MODEL UNKNOWN