BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 16009487 · Received December 19, 2022

    Report

    Report Number
    1037905-2022-00701
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 6, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. THIS MDR FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED 12/19/2022 RELATING TO THIS EVENT. THE INITIAL REPORT WAS SUBMITTED BASED ON THE UNCERTAINTY OF THE CLIP POSITION UPON DEPLOYING; TO ACCOUNT FOR THE POSSIBILITY THAT THE CLIP MAY HAVE DEPLOYED IN THE OPEN POSITION WHICH COULD HAVE REQUIRED MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY (RETRIEVAL OF THE FOREIGN OBJECT). ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINT FACILITY INDICATED THAT THE CLIP DEPLOYED IN THE CLOSED POSITION. THE INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE IS DESIGNED TO REMAIN IN THE PATIENT'S BODY AND PASS NATURALLY IN THE CLOSED POSITION, THEREFORE PREMATURELY DEPLOYING IN THE CLOSED POSITION DOES NOT POSE A RISK OF SERIOUS INJURY OR DEATH FOR THE PATIENT. BASED ON FURTHER QUALITY AND MEDICAL EVALUATION THIS INCIDENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323 THE INVESTIGATION IS ONGOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL INFORMATION SECTION FOR THIS JUSTIFICATION.

    Description of Event or Problem · 0

    DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE CLIP PREMATURELY DEPLOYED UPON EXITING THE SCOPE CHANNEL. 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
    2201613 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4637013 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS 190 UPPER SCOPE