BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC KITTNER DISSECTOR

    MDR report key: 6243048 · Received January 11, 2017

    Report

    Report Number
    2320762-2017-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 20, 2017
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    GDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE KITTNER DISSECTOR IS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (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 RESPONSE, (B)(4) HAS IDENTIFIED THE FOLLOWING CORRECTIVE ACTIONS: ADD MORE DETAILS TO THE MANUFACTURING PROCEDURE (MANUFACTURING OF ENDOKITTNER PC3060 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. ALL CORRECTIVE ACTIONS WERE DOCUMENTED IN (B)(4). CORRECTIONS: IN THE SCAR RESPONSE, (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 WERE REINSPECTED AT 100 PERCENT; DEROYAL RETURNED LOTS 16F2326, 16H3290, 16D1367 AND 16B0344 FOR REINSPECTION AT 100 PERCENT. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THE TIP OF A LAPAROSCOPIC KITTNER DISSECTOR (PART NUMBER 28-0801) CAME OFF THE PRODUCT DURING A PROCEDURE AND WAS RETRIEVED FROM THE PATIENT. THE LOT NUMBER HAS NOT BEEN REPORTED. ADDITIONALLY, THE DEFECTIVE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. IN THE INITIAL REPORT, THE END USER REPORTED THE SAMPLE WAS AVAILABLE FOR RETURN; HOWEVER, THE END USER DISCARDED THE PRODUCT. DUE TO THE ABSENCE OF A LOT NUMBER, THE WORK ORDER COULD NOT BE REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(4) SUPPLIES THE DISSECTOR TO DEROYAL INDUSTRIES. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4) ON JANUARY 3, 2017. A RESPONSE WAS RECEIVED JANUARY 12, 2017 AND ACCEPTED THE SAME DAY. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED FOR 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 RESPONSE, (B)(4) STATED THE AREA SUPERVISOR FOLLOWED UP WITH EACH OPERATOR TO ENSURE THE GLUING PROCESS IS PERFORMED CORRECTLY. THE PRODUCTION INSPECTOR WILL CONTINUE TO CHECK ALL STICKS FOR TIP RETENTION. ALL PREVENTIVE ACTIONS WERE DOCUMENTED IN (B)(4). THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THE TIP OF A LAPAROSCOPIC KITTNER DISSECTOR (PART NUMBER 28-0801) CAME OFF THE PRODUCT DURING A PROCEDURE AND WAS RETRIEVED FROM THE PATIENT. THE LOT NUMBER HAS NOT BEEN REPORTED. ADDITIONALLY, THE DEFECTIVE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. IN THE INITIAL REPORT, THE END USER REPORTED THE SAMPLE WAS AVAILABLE FOR RETURN; HOWEVER, THE END USER DISCARDED THE PRODUCT. DUE TO THE ABSENCE OF A LOT NUMBER, THE WORK ORDER COULD NOT BE REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(4) SUPPLIES THE DISSECTOR TO DEROYAL INDUSTRIES. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(6) ON JANUARY 3, 2017. A RESPONSE IS DUE FEBRUARY 15, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED FOR 2016. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN NEW AND CRITICAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING A LAP CHOLE PROCEDURE, THE TIP OF THE LAPAROSCOPIC KITTNER CAME OFF. THE TIP WAS RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    DURING A LAP CHOLE PROCEDURE, THE TIP OF THE LAPAROSCOPIC KITTNER CAME OFF. THE TIP WAS RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24467 LAPAROSCOPIC KITTNER DISSECTOR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI MEDSORB DOMINICANA, S.A. 28-0801 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1