BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP CHOLE KIT

    MDR report key: 6833565 · Received August 31, 2017

    Report

    Report Number
    3005011024-2017-00014
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    February 21, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FDE
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE DRAPE CONTAINED WITHIN THE FINISHED GOOD KIT (89-6201) IS SUPPLIED TO DEROYAL BY WELMED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO WELMED. THE VENDOR RESPONDED INDICATING THE FOAM REINFORCEMENT MATERIAL AROUND THE FENESTRATION NEEDED TO BE CHANGED. IT HAS CHANGED THIS MATERIAL TO A MORE DURABLE FIBER. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, WELMED STATED IT IS CHANGING ITS SPECIFICATIONS FOR THE FOAM REINFORCEMENT MATERIAL. WELMED HAS DOCUMENTED THIS ISSUE FOR TRENDING AND WILL CONTINUE TO MONITOR THE SITUATION IN ITS CAPA PROGRAM. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A LAP CHOLE PACK (FINISHED GOOD 89-6201, LOT 41912794) CONTAINED A FENESTRATED KEY DRAPE THAT WAS FLAKING, ALLOWING DEBRIS INTO THE SURGICAL SITE. THE SAMPLE WAS RETURNED FOR EVALUATION. DEROYAL QUALITY CONTROL PERSONNEL EVALUATED THE SAMPLE AND CONFIRMED THE DRAPE BORDER WAS FLAKING. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. AN INVENTORY CHECK COULD NOT BE COMPLETED BECAUSE DEROYAL NO LONGER KEEPS THIS COMPONENT (5-18466-D) ON HAND. THE LAST FINISHED GOOD PRODUCED WITH THIS RAW MATERIAL WAS MANUFACTURED IN JUNE 2016. THE AFFECTED DRAPE (RAW MATERIAL 5-18466-D) WAS SUPPLIED TO DEROYAL BY WELMED. A SCAR WAS SENT TO WELMED AND A RESPONSE HAS BEEN RECEIVED. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. 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 THAT A LAP CHOLE PACK (FINISHED GOOD 89-6201, LOT 41912794) CONTAINED A FENESTRATED KEY DRAPE THAT WAS FLAKING, ALLOWING DEBRIS INTO THE SURGICAL SITE. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE AFFECTED DRAPE (RAW MATERIAL (B)(4)) WAS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED AUGUST 15, 2017, AND A RESPONSE IS DUE SEPTEMBER 26, 2017. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE FENESTRATED KEY SHEET WAS FLAKING, WHICH LED TO DEBRIS IN THE SURGICAL SITE.

    Description of Event or Problem · 1

    THE FENESTRATED KEY SHEET WAS FLAKING, WHICH LED TO DEBRIS IN THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615776 LAP CHOLE KIT LAPAROSCOPY KIT FDE DEROYAL INDUSTRIES, INC. 89-6201 41912794

    Patients

    Seq Age Sex Outcome Treatment
    1