BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 15657863 · Received October 24, 2022

    Report

    Report Number
    1037905-2022-00587
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 18, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. HOWEVER, TEN SEALED DEVICES FROM THE LOT NUMBER SAID TO BE INVOLVED WERE RETURNED AND EVALUATED. ALL SEALED DEVICES: THE DEVICES WERE FUNCTIONALLY TESTED TO VERIFY OPEN/CLOSE AND THE CATH ATTACH TO HOUSING JOINT STRENGTH. ALL OF THE CLIPS ADVANCED THROUGH THE SCOPE, OPENED, AND CLOSED AS EXPECTED. ADDITIONALLY, THE CLIPS DID NOT SEPARATE FROM THE CATH ATTACH WHEN OPENED. A FUNCTIONAL TEST WAS THEN PERFORMED FOR THE HOUSING TO CATCH ATTACH JOINT TENSILE STRENGTH. SEALED DEVICES #1-6, #8-10: THESE DEVICES SEPARATED AT THE CATH ATTACH AT A DETACHMENT FORCE WITHIN THE ACCEPTANCE CRITERIA. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED FOR THESE SEALED DEVICES. SEALED DEVICE #7: THIS DEVICE SEPARATED AT THE CATH ATTACH WITH A DETACHMENT FORCE BELOW THE MINIMUM ACCEPTANCE LOAD. THE CATH ATTACH FOR THIS DEVICE WAS FURTHER MEASURED AND THE DIMENSIONS THAT COULD BE RELATED TO TROMBONING. ALL DIMENSIONS WERE WITHIN SPECIFICATION. THE COMPLAINT FOR THIS SEALED DEVICE IS CONFIRMED BASED ON THE FAILURE OF THE TENSILE TEST STRENGTH. 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: USED DEVICE: 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. SEALED DEVICE #7: THIS DEVICE FAILED TO MEET THE REQUIRED DETACHMENT FORCE FOR THE HOUSING TO CATH ATTACH JOINT STRENGTH, HOWEVER THE CATH ATTACH DIMENSIONS RELATED TO TROMBONING WERE WITHIN SPECIFICATION THEREFORE A ROOT CAUSE WAS NOT DETERMINED. SEALED DEVICES #1-6, #8-10: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 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. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE COMPLETE CLIP AND COLLAR REMAINED ATTACHED TO THE WIRE WHERE IT COULD BE EXTENDED AND WITHDRAWN WHILE REMAINING ATTACHED TO THE WIRE [MOVED IN A TROMBONING MANNER]. 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
    2821551 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4605136 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male OLYMPUS GIF-H190