BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 14648500 · Received June 9, 2022

    Report

    Report Number
    1037905-2022-00280
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 9, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K212323. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH PRODUCT EVALUATION INFORMATION.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K212323. CORRECTED DATA: D9- DEVICE AVAILABLE FOR EVALUATION = NO. CORRECTED FROM "YES". THE DEVICE WAS NOT RECEIVED. 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. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED AN INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. THE DEPLOYMENT OF THE CLIP WAS DIFFICULT BUT SUCCESSFUL. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE 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
    1171466 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4552621 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Male OLYMPUS DUODENAL SCOPE UNKNOWN MODEL NUMBER