BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 18155386 · Received November 16, 2023

    Report

    Report Number
    1037905-2023-00582
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 16, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002183438
    Adverse Event
    Yes
    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. 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 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. PRECAUTION: DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP." THE IFU STATES: "ENDOSCOPE MUST REMAIN AS STRAIGHT AS POSSIBLE WHEN INSERTING OR WITHDRAWING DEVICE." THE IFU STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING 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 ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL 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: 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 PROCEDURE FOR HEMOSTASIS IN THE STOMACH, THE PHYSICIAN USED TWO INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE CLIPS THEY PRE-MATURELY DEPLOYED [OPEN POSITION]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. HE USED HEMOSPRAY AND THE PROCEDURE WAS SUCCESSFUL. 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
    912025 INSTINCT ENDOSCOPIC HEMOCLIP PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC W4451576 00827002183438

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SCOPE, UNKNOWN MAKE AND MODEL