BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23

    MDR report key: 10295705 · Received July 20, 2020

    Report

    Report Number
    3005075853-2020-03665
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Report Date
    June 29, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014676
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U9326X. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: EMAIL RECEIVED ON 7/1: ¿ WHAT DO YOU MEAN BY THE OUTER CORNER PLASTIC WAS COMPLETELY BROKEN OFF.? A PLASTIC CORNER OF THE PLASTIC PACKAGING WAS MISSING, LOOKED LIKE IT HAD BROKEN OFF. WAS THE PACKAGING BROKEN OFF? YES! WAS THE HANDLE OF THE DEVICE BROKEN OFF? NO. DID THE ACTIVE TITANIUM BLADE BREAK OFF? NO. DID THE WHITE TISSUE PAD BREAK OFF? NO. IS THE WHITE TISSUE PAD COMPLETELY MISSING FROM THE CLAMP ARM OF THE DEVICE? NO. EMAIL RECEIVED ON 7/8: "¿ WHAT DO YOU MEAN BY THE OUTER CORNER PLASTIC WAS COMPLETELY BROKEN OFF? WHEN YOU GO TO PULL THE TYVEK COVERING BACK TO OPEN THE PACKAGE, THERE IS PLASTIC UNDER THE TYVEK. A CORNER PIECE OF THE PLASTIC OUTSIDE OF THE STERILE PORTION OF THE PACKAGE WAS COMPLETELY BROKEN OFF. THE PLASTIC CORNER SHOULD HAVE BEEN PRESENT AND IT WAS NOT. WAS THE HANDLE OF THE DEVICE BROKEN OFF? NO THIS WAS ALL ON THE OUTSIDE OF THE STERILE PORTION. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE HARH23 DEVICE WAS RETURNED INSIDE ITS PACKAGE UNOPENED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BLISTER FROM THE PACKAGING WAS DAMAGED. IT WAS BROKEN AND STILL ADHERED TO THE TYVEK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. DUE TO THE DAMAGE FOUND ON THE BLISTER, A POSSIBLE CAUSE FOR THIS CONDITION IS DUE TO IMPROPER HANDLING DURING TRANSIT OR STORAGE. IT APPEARS THAT THE PACKAGE HIT A HARD SURFACE AND THIS CAUSED THE REPORTED EVENT. THE REPORTED COMPLAINT WAS CONFIRMED. ALL EES PRODUCT IS 100% INSPECTED PRIOR TO RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE PACKAGING WAS OPENED, A CORNER PIECE OF THE PLASTIC OUTSIDE OF THE STERILE PORTION OF THE PACKAGE WAS COMPLETELY BROKEN OFF. THE PLASTIC CORNER SHOULD HAVE BEEN PRESENT AND IT WAS NOT. THIS WAS ALL ON THE OUTSIDE OF THE STERILE PACKAGING. NEITHER THE TITANIUM BLADE NOR THE WHITE TISSUE PAD WERE DAMAGED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760366 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARH23 U9325X 10705036014676

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE