BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL LAP PACK

    MDR report key: 5463327 · Received February 26, 2016

    Report

    Report Number
    3005011024-2016-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 25, 2016
    Report Date
    May 11, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE DEFECTIVE ITEM WITHIN FINISHED GOOD 89-7041 HAS BEEN IDENTIFIED AS A CARBON STEEL BLADE #11 (RAW MATERIAL 5-3205), WHICH IS SUPPLIED BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO ASPEN AS WELL AS THE DEFECTIVE SAMPLE. THE SUPPLIER HAS IDENTIFIED THE ROOT CAUSE AS INHERENT PROCESS VARIABILITY DURING THE GRINDING PROCESS. GRINDING THE WHEEL, STROPPING THE WHEEL, AND CHUCK CONDITION COULD BE POTENTIAL CAUSES OF THE BLADE'S DULL CONDITION. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: THE SUPPLIER REPORTED IN ITS SCAR RESPONSE THAT A CAPA WAS INITIATED NOVEMBER 26, 2013, AND COMPLETED APRIL 30, 2016 TO ADDRESS THE "DULL CONDITION" OF BLADES. ACTIONS WERE LISTED AS THE FOLLOWING: TRANING TO PRODUCTION PERSONNEL AND QUALITY INSPECTORS IN VISUAL INSPECTIONS; ANNUAL RE-CERTIFICATION ON BLADE DEFECTS; TRAINING TO PRODUCTION PERSONNEL ON GRINDING/STROPPING SETUP IDENTIFICATION OF WHEEL CONDITION AND DETECT WHEN CONSUMABLE PARTS NEED REPLACEMENT; GRINDING MACHINES PREVENTIVE MAINTENANCE MONITORED; SPEED OF GRINDER MACHINE CONTROLLED; BLANKS CONDITION INSPECTION; A 100 PERCENT VISUAL INSPECTION BY CERTIFIED PERSONNEL TO SORT NON-CONFORMING PARTS, INCLUDING DULL BLADE, PRIOR ASSEMBLY AND PACKAGING PROCESS; IN-PROCESS INSPECTION EVERY 30 MINUTES TO IDENTIFY NON-CONFORMANCE CONDITION; AND UPDATE FORM TO VERIFY AND DOCUMENT SPEED GRINDER MACHINE. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT FINISHED GOOD 89-7041 (A GENERAL LAP PACK) CONTAINED A CARBON STEEL BLADE #11 THAT WAS "DULL AND DID NOT CUT THE WAY IT HAS IN THE PAST." THE DEFECTIVE BLADE HAS BEEN IDENTIFIED AS RAW MATERIAL 5-3205. (B)(4) SUPPLIES THE RAW MATERIAL. THE QUALITY CONTROL COMPLAINT SPECIALIST REVIEWED THE WORK ORDER FOR DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NONE WERE IDENTIFIED. THE FINISHED GOOD AND LOT NUMBER REPORTED CONTAINED RAW MATERIAL 5-3205, LOT NUMBER 0074080. THE RAW MATERIAL REMAINS INSIDE THE VENDOR PACKAGING DURING THE MANUFACTURING PROCESS. THEREFORE, DISCREPANCIES WOULD NOT HAVE BEEN IDENTIFIED DURING DEROYAL'S MANUFACTURING. THE 2014-2016 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. NONE WERE IDENTIFIED; HOWEVER, DUE TO THE NATURE OF THE COMPLAINT, A SCAR WAS ISSUED TO (B)(4) WITH A DUE DATE OF MARCH 7, 2016. AN EMAIL WAS SENT FEBRUARY 16, 2016, TO (B)(4) NOTIFYING THE VENDOR OF THE SAMPLE'S AVAILABILITY. THE ACTUAL SAMPLE WAS FORWARDED FEBRUARY 18, 2016, TO (B)(4). (B)(4) RESPONDED TO THE SCAR ON APRIL 28, 2016. PREVENTIVE ACTION: THE SUPPLIER IDENTIFIED A PREVENTIVE ACTION OF MONITORING THE GRINDING SPEED MACHINE AND REPLACING CONSUMABLE PARTS WHEN IDENTIFIED. THE INVESTIGATION COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE TRUE ROOT CAUSE IS UNDETERMINED AT THIS TIME. (B)(4). CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: (B)(4). THE QUALITY CONTROL COMPLAINT SPECIALIST REVIEWED THE WORK ORDER FOR DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NONE WERE IDENTIFIED. (B)(4). THE 2014-2016 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. NONE WERE IDENTIFIED; HOWEVER, DUE TO THE NATURE OF THE COMPLAINT, A SCAR WAS ISSUED TO ASPEN SURGICAL WITH A DUE DATE OF MARCH 7, 2016. AN EMAIL WAS SENT FEBRUARY 16, 2016, TO ASPEN SURGICAL NOTIFYING THE VENDOR OF THE SAMPLE'S AVAILABILITY. THE ACTUAL SAMPLE WAS FORWARDED FEBRUARY 18, 2016, TO ASPEN SURGICAL. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE NUMBER 11 BLADE WAS DULL AND DID NOT CUT THE WAY IT HAS IN THE PAST. THE BLADE APPEARS DULL IN COLOR, AND WHEN COMPARED TO THE SINGLE PULL BLADE, IT DOES NOT PERFORM THE SAME WAY. THE CIRCULATOR HAD TO THE LEAVE THE ROOM TO GET A SINGLE PULL BLADE. THE BLADE HAD TO BE LOADED, WHICH CAUSED DELAY. OUTCOME TO THE PATIENT: THE PATIENT'S SKIN APPEARED TORN AND UNEVEN. CLOSURE WAS A LITTLE MORE CHALLENGING, AND THE INCISION SITE WAS NOT AS CLEAN AS USUAL.

    Description of Event or Problem · 1

    THE NUMBER 11 BLADE WAS DULL AND DID NOT CUT THE WAY IT HAS IN THE PAST. THE BLADE APPEARS DULL IN COLOR, AND WHEN COMPARED TO THE SINGLE PULL BLADE, IT DOES NOT PERFORM THE SAME WAY. THE CIRCULATOR HAD TO THE LEAVE THE ROOM TO GET A SINGLE PULL BLADE. THE BLADE HAD TO BE LOADED, WHICH CAUSED DELAY. OUTCOME TO THE PATIENT: THE PATIENT'S SKIN APPEARED TORN AND UNEVEN. CLOSURE WAS A LITTLE MORE CHALLENGING, AND THE INCISION SITE WAS NOT AS CLEAN AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121167 GENERAL LAP PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 40960081

    Patients

    Seq Age Sex Outcome Treatment
    1