BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13998051 · Received April 4, 2022

    Report

    Report Number
    1037905-2022-00154
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 5, 2022
    Report Date
    May 2, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K212323. THE INVESTIGATION IS ONGOING. A FOLLOW UP EMDR REPORT WILL BE SENT WITHIN 30 DAYS OF SUBMISSION FOR THE COMPLETED INVESTIGATION AND DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    510(K): K212323. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT AS IT WAS DESCRIBED. THE DEVICE WAS RETURNED WITH THE CLIP ATTACHED IN THE CLOSED POSITION. DURING TESTING THE HANDLE WAS MANIPULATED BEFORE ADVANCING THROUGH THE SCOPE, THE CLIP OPENED AND CLOSED AS INTENDED. A FUNCTION TEST WAS ATTEMPTED, IN ORDER TO DEPLOY THE CLIP. HOWEVER, WITH HANDLE MANIPULATION AND LIGHT TOUCHING OF THE CLIP ON THE TABLE, THE DEVICE WOULD NOT DEPLOY THE CLIP. UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COILED CATH APPEARED TO BE SLIGHTLY FLATTENED/MISSHAPEN AT THE DISTAL END PREVENTING THE CATH ATTACH FROM MOVING PROPERLY.¿ THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION. THE FOLLOWING INFORMATION WAS PROVIDED: ¿UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COIL CATH APPEARS TO BE SLIGHTLY FLATTENED/MISSHAPEN AT THE DISTAL END. OUR LABORATORY EVALUATION OF THE RETURNED PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT AS IT WAS DESCRIBED. UNDER VISUAL MAGNIFICATION THE COIL CATH APPEARS TO BE SLIGHTLY FLATTENED/MISSHAPEN. THIS WOULD PREVENT THE CATH ATTACH FROM SEPARATING FROM THE DEVICE TIP. THE DEVICE HISTORY RECORDS FOR THE LOT NUMBER WERE REVIEWED, MANUFACTURED NOVEMBER 2021. THERE WERE NO RELEVANT DEFECTS." 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: THE SUPPLIER PROVIDED THE FOLLOWING INFORMATION: "ROOT CAUSE COULD NOT BE DETERMINED. TEAM LEADS AND OPERATORS ON THE INSTINCT PLUS LINE WILL BE ADVISED OF THE COMPLAINT. THE COMPLAINT WAS ISSUED AS A HEIGHTENED AWARENESS/FDA REPORTABLE. A REVIEW OF THE DEVICE RECORD DID NOT REVEAL ANY NONCONFORMITIES ASSOCIATED WITH THE USER'S COMPLAINT. A FUNCTIONAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMERS COMPLAINT. THE EVALUATION OF THE DEVICE FOUND THE COIL CATH TO BE SLIGHTLY FLATTENED / MISSHAPEN WHICH WOULD PREVENT THE CATH ATTACH FROM SEPARATING FROM THE DEVICE TIP. ROOT CAUSE COULD NOT BE DETERMINED. ATTEMPTS TO RE-CREATE THE EVENT, SPECIFICALLY, FLATTENING OF THE COIL CATH WERE NOT SUCCESSFUL. ALL DEVICES ARE VERIFIED TO FUNCTION AS INTENDED PRIOR TO BEING PACKAGED OPERATORS WILL BE ADVISED OF THE COMPLAINT." THE INSTRUCTIONS FOR USE STATES, "NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP." PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 A HEMOSTASIS PROCEDURE, A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE WAS USED. THE USER WAS ABLE TO OPEN AND CLOSE THE CLIP AND ATTACH TO TARGET SITE, HOWEVER; ONCE ATTACHED TO THE TARGET SITE, THE CLIP WOULD NOT RELEASE. THE USER WAS EVENTUALLY ABLE TO OPEN THE CLIP TO REMOVE IT FROM THE TARGET SITE, CLOSE THE CLIP, AND REMOVE THE ENTIRE DEVICE THROUGH THE SCOPE. AN UNINTENDED 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
    1089038 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4537751 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS GIF-H190 SCOPE.