BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 12830978 · Received November 17, 2021

    Report

    Report Number
    1037905-2021-00635
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    September 8, 2021
    Report Date
    November 17, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002347806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. INVESTIGATION EVALUATION: OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THERE IS WIRE GUIDE COATING DAMAGE NEAR THE DISTAL END. APPROXIMATELY 15.4CM TO 15.8CM AND 16.6CM TO 17.1CM FROM THE DISTAL END ARE SECTIONS OF BARE CORE WIRE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS NONCONFORMANCE'S THAT COULD POTENTIALLY BE RELATED TO COATING DAMAGE. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IF ADDITIONAL PRESSURE IS APPLIED TO THE WIRE GUIDE AND/OR ACCESSORY DEVICE(S) WHILE MOVING THE WIRE GUIDE INSIDE THE ACCESSORY DEVICE(S), THIS COULD CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE ARE SUBJECTED TO A VISUAL INSPECTION 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: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE WIRE CAME OFF. A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS CARRIED OUT AS PLANNED. 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
    1729727 D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G34780 W4410800 10827002347806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE, UNKNOWN MAKE OR MODEL