BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 17119733 · Received June 13, 2023

    Report

    Report Number
    1037905-2023-00296
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 13, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K2212323. 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF THE CLIP HOUSING DETACHING FROM THE CATH ATTACH FOR INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. THE INSTRUCTIONS FOR USE STATES: "UNCOIL DEVICE. VERIFY SMOOTH HANDLE OPERATION AND CLIP ACTION. OPEN CLIP BY GENTLY MOVING HANDLE SPOOL DISTALLY (AWAY FROM HANDLE THUMB RING). ONCE CLIP IS FULLY OPEN, DO NOT CONTINUE ADVANCING HANDLE SPOOL AS CLIP MAY PREMATURELY DETACH FROM CATHETER. CLOSE CLIP BY MOVING HANDLE SPOOL PROXIMALLY UNTIL CLIP IS FULLY CLOSED. PRECAUTION: DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP." THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND HOLD FOR JF 6.27. WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE, DUODENOSCOPE, OR COLONOSCOPE. NOTE: IF DIFFICULT TO ADVANCE DEVICE, RELAX ELEVATOR AND/OR STRAIGHTEN ENDOSCOPE.¿ THE IFU ALSO INCLUDES THE FOLLOWING PRECAUTION: ¿HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP.¿ FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. 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 ENDOSCOPY, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT AFTER THE CLIP WAS PUT DOWN THE DUODENOSCOPE, THE CLIP DETACHED FROM THE CATHETER AND STAYED ATTACHED TO THE DRIVE WIRE TIP. 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
    2216065 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SCOPE, UNKNOWN MAKE AND MODEL