BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER DISSECTOR

    MDR report key: 6124046 · Received November 23, 2016

    Report

    Report Number
    2320762-2016-00025
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    GDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE RAW MATERIAL IS SUPPLIED TO (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) REV. Q) 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. THE WORK ORDER WAS REVIEWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE WERE IDENTIFIED. RAW MATERIAL (B)(4) IS USED WITHIN FINISHED GOOD (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 TIP BROKE OFF OF THE END OF THE INSTRUMENT INSIDE OF THE PATIENT DURING A LAPAROSCOPIC HIATAL HERNIA SURGERY. SURGEON IMMEDIATELY DISCOVERED IT BROKE OFF AND WAS ABLE TO RETRIEVE IT FROM THE PATIENT WITH NO HARM CAUSED. THE DELAY IN THE PROCEDURE WAS THE TIME FOR THEM TO GET A REPLACEMENT PRODUCT, WHICH LASTED ABOUT FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776659 KITTNER DISSECTOR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI MEDSORB DOMINICANA, S.A. 28-0801 43207669

    Patients

    Seq Age Sex Outcome Treatment
    1