BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3952573 · Received May 15, 2014

    Report

    Report Number
    1037905-2014-00188
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FHN
    PMA / PMN Number
    K132809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. TWO SEALED DEVICE FROM THE LOT NUMBER SAID TO BE INVOLVED IN THE REPORT WERE INCLUDED IN THE RETURN. DEVICE #1, SEALED: THE DEVICE WAS RETURNED IN A SEALED POUCH. THE DEVICE WAS EXAMINED UNDER HIGH MAGNIFICATION AND THE DEVICE SHOWED THE PRESENCE OF COINED EDGES ON BOTH SIDES OF BOTH CLIP JAWS. THE DEVICE WAS ADVANCED INTO AN OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. THE CLIP WAS SUCCESSFULLY OPENED AND CLOSED BY APPLYING AN EXPECTED AMOUNT OF FORCE TO THE HANDLE SPOOL. THIS DEVICE WAS RETURNED TO THE APPROVED SUPPLIER FOR FURTHER EVALUATION. DEVICE #2, SEALED: THE DEVICE WAS RETURNED IN A SEALED POUCH. THE DEVICE WAS EXAMINED UNDER HIGH MAGNIFICATION AND THE DEVICE SHOWED THE PRESENCE OF COINED EDGES ON BOTH SIDES OF BOTH CLIP JAWS. THE DEVICE WAS ADVANCED INTO AN OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST CASE POSITION. THE CLIP WAS SUCCESSFULLY OPENED AND CLOSED BY APPLYING AN EXPECTED AMOUNT OF FORCE TO THE HANDLE SPOOL. THIS DEVICE WAS RETURNED TO THE APPROVED SUPPLIER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE GENERATED ONCE THE EVALUATION FROM THE SUPPLIER IS RECEIVED. 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. WE CANNOT ADEQUATELY DETERMINE A ROOT CAUSE AT THIS TIME BECAUSE THE INVESTIGATION IS STILL IN PROGRESS AT OUR APPROVED SUPPLIER. PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS 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 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 · 1

    DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. AFTER CLOSING THE CLIP ONTO THE TARGET AREA, THE CLIP WOULD NOT DEPLOY AS IT STAYED ATTACHED TO THE CATHETER AND COULD NOT BE REOPENED. THE PHYSICIAN HAD TO TEAR THE CLIP FROM THE TISSUE. 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
    291223 INSTINCT ENDOSCOPIC HEMOCLIP FHN WILSON-COOK MEDICAL INC W3402658

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX ENDOSCOPE, MODEL UNK