BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPERED SURGICAL TOGA, XL BS EN 166 Z 166 1F

    MDR report key: 7273260 · Received February 15, 2018

    Report

    Report Number
    0001526350-2018-00149
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FYA
    PMA / PMN Number
    PK132386
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) FOR THE TOTALSHIELD SURGICAL HOOD , PART NUMBER 00990031210 AND LOT NUMBER D162863, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2018, IT WAS REPORTED FROM NORTON AUDUBON HOSPITAL THAT A TOTALSHIELD ZIPPERED SURGICAL TOGA, XL BS EN 166 Z 166 1F HAD FLUID SOAKING THROUGH IT REACHING THE SURGEON. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE TOTALSHIELD ZIPPERED SURGICAL TOGA, XL BS EN 166 Z 166 1F, PART NUMBER (B)(4), REVIEW COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THE REPORTED EVENT. ON (B)(6) 2018, IT WAS REPORTED FROM NORTON AUDUBON HOSPITAL THAT A TOTALSHIELD ZIPPERED SURGICAL TOGA, XL BS EN 166 Z 166 1F HAD FLUID SOAKING THROUGH IT REACHING THE SURGEON. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. DEVICE WAS NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID (WATER & BLOOD) WAS SOAKING THROUGH THE TOGAS AND REACHING THE SURGEON TWICE DURING AN ORTHO JOINT REVISION CASE. THE TOGA SOAKED BLOOD THROUGH THE ARMS AND THE WAIST OF THE SURGEON. THE ISSUE COULD PUT PATIENTS AT A GREAT RISK OF DEVELOPING AN SSI (SURGICAL SITE INFECTION). THE SURGEON HAD EXPOSURE TO PATIENT'S BLOOD AND BODY FLUIDS DUE TO THE TOGA LEAKING, THIS LED TO POSSIBLE BLOOD BORNE PATHOGEN (BBP) EXPOSURE TO THE SURGEON. IT IS ASSUMED THE SURGEON HAD EXPOSURE TO INTACT SKIN, IT IS UNKNOWN IF THE SURGEON WAS TREATED BY FACILITIES BBP PROTOCOL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118004 ZIPPERED SURGICAL TOGA, XL BS EN 166 Z 166 1F GOWN, SURGICAL FYA ZIMMER SURGICAL, INC. N/A D162863

    Patients

    Seq Age Sex Outcome Treatment
    1