BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12345022 · Received August 19, 2021

    Report

    Report Number
    1037905-2021-00414
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 12, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K192697. AT THIS TIME, THIS INVESTIGATION IS STILL IN PROCESS. FURTHER INFORMATION WILL BE PROVIDED IN A SUBSEQUENT FOLLOW UP EMDR.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K192697. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT AS IT WAS DESCRIBED. THE DEPLOYED CLIP WAS RETURNED ATTACHED TO THE DEVICE IN THE CLOSED POSITION. UNDER VISUAL MAGNIFICATION, THE CATH ATTACH WAS OBSERVED OUTSIDE OF THE HOUSING AND ATTACHED AT THE PROXIMAL END OF THE CLIP. THE COIL CATH TABS DO NOT APPEAR CRIMPED, THIS WOULD ALLOW THE CATH ATTACH TO SLIDE OUT OF THE HOUSING AND REMAIN ATTACHED TO THE CLIP. A FUNCTION TEST WAS ATTEMPTED, IN ORDER TO DEPLOY THE CLIP. HOWEVER, WITH HANDLE MANIPULATION AND LIGHT TOUCHING OF THE CLIP ON THE TABLE, THE DEVICE WOULD NOT DEPLOY THE CLIP. THE DEVICE WAS SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER PROVIDED THE FOLLOWING: VISUAL EVALUATION: THE DEVICE TIP IS DEPLOYED AND RETURNED SEPARATED FROM THE COILED CABLE. THE COIL CATH TABS ARE NOT CRIMPED. FUNCTIONAL EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. A FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE DEVICE TIP HAS BEEN DEPLOYED. [CLIP PRESUMABLY DEPLOYED DURING SHIPPING] THE RETURNED COMPONENTS WERE LOOKED AT UNDER MAGNIFICATION. JAWS ARE CONTACTING TOP OF HOUSING. PINS ARE BOTTOMED OUT IN HOUSING SLOTS. CATH ATTACH IS CONTACTING THE TABS IN THE COIL CATH. THESE CONDITIONS INDICATE THAT THE DEVICE TIP HAS BEEN DEPLOYED AS INTENDED. IT IS UNKNOWN AS TO WHY IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY. THE INSTINCT PLUS MANUFACTURING PROCESS ARE MONITORED DAILY TO VERIFY THEY MEET THEIR INTENDED REQUIREMENTS. THE COIL CATH TABS ALLOW FOR THE TIP TO ROTATE AND HOLD THE HOUSING TO THE COIL CATH SO THAT THE DEVICE TIP CAN OPEN. SINCE THE CATH ATTACH IS SEPARATED FROM THE HOUSING AND IS CONTACTING THE TABS OF THE COIL CATH IT CAN BE DETERMINED THAT THEY DID NOT INTERFERE WITH THE DEPLOYMENT OF THE DEVICE TIP. THE COMPLAINT WAS NOT CONFIRMED [DEPLOYMENT DIFFICULTY, INSUFFICIENT CRIMP WAS CONFIRMED]. THE DEVICE HISTORY RECORDS FOR PROCESS TRAVELER (PT) W4462065 (160) MANUFACTURED APRIL 2021 WERE REVIEWED. THE MANUFACTURING RECORDS AND/OR FQC CHECKLIST DID NOT INDICATE RELEVANT DEFECTS. 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: THE ROOT CAUSE IS AN INCORRECTLY MANUFACTURED THE DEVICE. THE CAUSE OF THE MANUFACTURING FAILURE IS UNKNOWN. THE SUPPLIER HAS INITIATED A CHANGE TO THEIR PROCESS TO INCLUDE ADDITIONAL VERIFICATIONS THAT WILL PREVENT REOCCURRENCE. THE SUPPLIER PROVIDED THE FOLLOWING: CORRECTIVE ACTIONS WERE IMPLEMENTED FOR VISUAL STANDARDS, PROCESS VERIFICATION, AND REVISION OF WORK INSTRUCTIONS. ALL OPERATORS INVOLVED IN THE INSTINCT PLUS CLIP ASSEMBLY HAVE BEEN TRAINED ON THESE DOCUMENTS. THE COMPLAINT WAS CONFIRMED AND CORRECTIVE ACTIONS HAVE BEEN INITIATED. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K192697 A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH THE COMPLETED INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. THE CLIP WOULD NOT DEPLOY. THE USER COULD NOT ULTIMATELY DEPLOY THE DEVICE. THE USER WAS ABLE TO GET CLIP BACK OFF THE TISSUE. NO BLEEDING OR TEARING OCCURRED AS A RESULT OF THIS. 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
    1241050 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4462065 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS COLONOSCOPE, 190 SERIES.