BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 W ADV HEMOSTASIS

    MDR report key: 7044879 · Received November 20, 2017

    Report

    Report Number
    3005075853-2017-06220
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    20705036014628
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # P93000. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED AND 100% PRESENT. IN ADDITION, THE TISSUE PAD WAS ATTACHED TO THE CLAMP ARM AND NOT DETACHED AS REPORTED BY THE CUSTOMER. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GEN11 AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. PROLONGED USAGE OF ADVANCED HEMOSTASIS MODE MAY CAUSE TISSUE PAD DAMAGE. KEEP THE CLAMP ARM OPEN WHEN BACK-CUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE BATCH HISTORY RECORD WAS REVIEWED AND THERE WERE NO DEFECTS, PROTOCOLS OR NCR(S) FOUND DURING THE MANUFACTURING PROCESS RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE TISSUE PAD WAS DETACHED. BUT THE PIECE WAS RETRIEVED. THE DEVICE WAS USED ON THE COLON. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826488 HARMONIC ACE PLUS 7 W ADV HEMOSTASIS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. P93000 20705036014628

    Patients

    Seq Age Sex Outcome Treatment
    1