BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2112546 · Received May 26, 2011

    Report

    Report Number
    1037905-2011-00336
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K023903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS RETURNED TO THE APPROVED CLIP SUPPLIER. THE RESULTS OF THE SUPPLIER'S EVALUATION INDICATED THE DEVICE OPENED, CLOSED AND ROTATED SMOOTHLY. HOWEVER, IT WAS OBSERVED THAT THE GEAR WAS INCORRECTLY INSERTED INTO THE DRIVER. BASED ON THIS INFORMATION, THE SUPPLIER HAS CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENT TO BE INCORRECT ASSEMBLY OF THE GEAR INTO THE DRIVER. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: THE RETURNED DEVICE DID NOT MEET THE APPLICABLE MANUFACTURING SPECIFICATIONS DUE TO INCORRECT ASSEMBLY AT THE SUPPLIER LEVEL. CORRECTIVE ACTION: A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO ADDRESS THE ROOT CAUSE OF INCORRECT ASSEMBLY. THE SUPPLIER HAS REVISED ASSEMBLY PROCEDURES TO CLARIFY REQUIREMENTS AND IMPLEMENTED AN INSPECTION USING MAGNIFICATION TO VERIFY PROPER ASSEMBLY. THESE CORRECTIVE ACTIONS BECAME EFFECTIVE ON (B)(4) 2011 AND WE CAN CONFIRM THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE CORRECTIVE ACTIONS. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE INFORMATION RELATED TO THIS OCCURRENCE WAS PROVIDED VIA COMPLETION OF A MARKETING EVALUATION QUESTIONNAIRE. DURING A POLYPECTOMY PROCEDURE IN THE COLON, THE PHYSICIAN USED A COOK DISPOSABLE HEMOSTASIS CLIP. ACCORDING TO THE QUESTIONNAIRE, THE USER IS UNSATISFIED WITH THE EASE OF USE. ALSO, THE ADDITIONAL COMMENT SECTION INDICATED "THE CLIP OPENED AND CLOSED PRIOR TO INSERTION. ONCE THE TISSUE WAS GRABBED THE CLIP WOULD NOT RELEASE. THE CLIP WAS REMOVED FROM THE CHANNEL STILL INTACT." THE ADDITIONAL INFORMATION ABLE TO BE COLLECTED INDICATED THE CLIP WAS NOT ABLE TO BE OPENED FOR REMOVAL FROM THE CLIPPING SITE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W2987969

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS (B)(4) ENDOSCOPE