BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED 5

    MDR report key: 10677896 · Received October 14, 2020

    Report

    Report Number
    9681407-2020-00059
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 13, 2020
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HILLROM/TRUMPF MEDICAL INVESTIGATED THE EVENT AND RELEVANT PARTS OF THE AFFECTED DEVICE. NO MALFUNCTION OR DEVIATION FROM THE SPECIFICATION WAS IDENTIFIED. A TEST WITH A HILLROM/TRUMPF MEDICAL STERILE HANDLE PASSED, IT WAS NOT ABLE TO DETACH THE HANDLE WITHOUT PRESSING THE RELEASE BUTTON. HOWEVER, THE INVOLVED ASPEN MEDICAL STERILE HANDLE WAS NOT AVAILABLE FOR INVESTIGATION. AS A CONCLUSION, THE HILLROM/TRUMPF MEDICAL DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE MOST LIKELY ROOT CAUSE WAS IDENTIFIED TO BE THE ASPEN MEDICAL STERILE HANDLE. ASPEN MEDICAL WAS NOTIFIED ABOUT THE COMPLAINTS. ACCORDING TO THE IFU THE CUSTOMER IS RESPONSIBLE TO ENSURE TO HAVE A COMPATIBILITY DECLARATION IS CASE OTHER MANUFACTURERS STERILE HANDLES ARE USED AT HILLROM/TRUMPF MEDICAL LIGHT HEADS. HILLROM/TRUMPF MEDICAL ALLOWS ONLY THE USED OF HILLROM/TRUMPF MEDICAL HANDLES PER THE IFU.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED A STERILE HANDLE FROM THE COMPANY ASPEN SURGICAL WAS ATTACHED TO THE ILED 7 LIGHT HEAD. THE HANDLE DETACHED AND FELL INTO THE STERILE FIELD DURING SURGERY. NO PATIENT OR CAREGIVER INJURY WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE STERILE HANDLE FELL INTO THE STERILE FIELD DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE SURGICAL LIGHT/HANDLES AT THIS TIME. THE INVESTIGATION IS ONGOING. ANY ADDITIONAL RELEVANT INFORMATION IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A STERILE HANDLE FROM THE COMPANY ASPEN SURGICAL WAS ATTACHED TO THE I-LED 7 LIGHT HEAD. THE HANDLE DETACHED, AND FELL INTO THE STERILE FIELD DURING SURGERY. NO PATIENT OR CAREGIVER INJURY WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145219 ILED 5 SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4047020

    Patients

    Seq Age Sex Outcome Treatment
    1