BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER DISSECTOR

    MDR report key: 6124009 · Received November 23, 2016

    Report

    Report Number
    2320762-2016-00023
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    GDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE RAW MATERIAL IS SUPPLIED TO DEROYAL INDUSTRIES, INC. BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE (B)(4). IN ITS RESPONSE, (B)(4) STATED ITS INVESTIGATION DETERMINED SOME GLUE OPERATORS USED A SLIGHTLY VARIED METHOD OF WRAPPING TAPE ON THE END OF THE STICK. THIS VARIATION LEFT THE POTENTIAL FOR GLUE TO BE IN THE INCORRECT AREA OF THE TAPE. ADDITIONALLY, A GAP WAS IDENTIFIED IN THE TRAINING OF OPERATORS WHO HAD BEEN IN THE POSITION FOR LESS THAN 1 YEAR. CORRECTIVE ACTION: IN THE SCAR, (B)(4) HAS IDENTIFIED THE FOLLOWING CORRECTIVE ACTIONS: ADD MORE DETAILS TO THE MANUFACTURING PROCEDURE (MANUFACTURING OF ENDOKITTNER (B)(4)) TO CLARIFY THE STEPS OF THE GLUING PROCESS; RETRAIN ALL OPERATORS ON PROPER TIP FOLDING, GLUING, AND WRAPPING TECHNIQUES; AND SUPERVISOR WILL FOLLOW-UP TO ENSURE ALL OPERATORS ARE TRAINED ON THE MANUFACTURING PROCEDURE AND RELATED QUALITY DOCUMENTATION. CORRECTIONS: IN THE SCAR, (B)(4) HAS STATED PERSONNEL INVOLVED WERE NOTIFIED THROUGH WRITTEN NOTIFICATION ABOUT THE NON-CONFORMITY; INVENTORY VERIFICATION AT THE (B)(4) WAREHOUSE WAS PERFORMED AND LOTS 4K303 AND 16H3290 WILL BE REINSPECTED AT 100%; DEROYAL WILL RETURN LOTS 16F2326, 16H3290, 16D1367, AND 16B0344 TO (B)(4) FOR REINSPECTION AT 100%. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT THE SPONGE TIP OF A KITTNER DISSECTOR ((B)(4)) HAD FALLEN INTO A PATIENT DURING A PROCEDURE. A LOT NUMBER WAS NOT REPORTED. THE POTENTIAL LOT NUMBERS WERE REVIEWED AND NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE WERE IDENTIFIED. (B)(4) IS USED WITHIN FINISHED (B)(4). THE RAW MATERIAL IS SUPPLIED BY (B)(4). THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER (SNL) LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED IN 2016. A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE WAS RECEIVED NOVEMBER 21, 2016. AS A RESULT OF THE VENDOR INVESTIGATION, DEROYAL HAS PLACED THE PRODUCT UNDER PURCHASE INSPECTION AND ASSIGNED VERIFICATION OF THE COMPLAINT. PREVENTIVE ACTION: IN THE SCAR, (B)(4) HAS STATED THE AREA SUPERVISOR WILL BE MONITORING EACH OPERATOR TO ENSURE THE GLUING PROCESS IS PERFORMED CORRECTLY. THE PRODUCTION INSPECTOR WILL CONTINUE TO CHECK ALL STICKS FOR TIP RETENTION. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SPONGE AT THE TIP FELL INTO PATIENT DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776242 KITTNER DISSECTOR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI MEDSORB DOMINICANA, S.A. 28-0801 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1