BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13026085 · Received December 17, 2021

    Report

    Report Number
    1037905-2021-00703
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 23, 2021
    Report Date
    January 14, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP EMDR WILL BE SENT WITHIN 30 DAYS FOR THE COMPLETED INVESTIGATION. THE INVESTIGATION IS CURRENTLY ON-GOING.

    Additional Manufacturer Narrative · 0

    510(K): K212323. THIS REPORT HAS CHANGED FROM A MALFUNCTION TO A SERIOUS INJURY BASED ON CLARIFICATION OF THE INTERVENTION THAT OCCURRED. 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: 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 SYSTEM PREPARATION SECTION OF THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING: "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. CAUTION: DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP." 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 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 CLIPPING PROCEDURE, THREE COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES WERE USED. THE CLIP WOULD NOT OPEN. WHEN THE TECHNICIAN TRIED TO OPEN THE CLIP, IT WOULD NOT OPEN, BUT INSTEAD SEPARATED FROM THE OUTER CATHETER AND PROTRUDED OUT, WHILE STILL BEING ATTACHED TO THE INNER WIRE HOLDING ON TO THE CLIP [IN A TROMBONING FASHION]. THE USER SWITCHED TO A COMPETITOR CLIPPING DEVICE AND THEN USED HEMOSPRAY TO COMPLETE THE PROCEDURE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE; ADDITIONAL COMPETITOR CLIPS AND HEMOSPRAY WERE USED. 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
    1924426 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY UNKNOWN

    Patients

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