BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 5042906 · Received August 31, 2015

    Report

    Report Number
    3005075853-2015-05462
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 7, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED WITH THE TISSUE PAD DETACHED AND NOT RETURNED BUT WITH EVIDENCE OF BODY FLUIDS AND TISSUE PAD MATERIAL IN THE GROOVE SECTION OF THE CLAMP ARM. 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. BASED ON THE CONDITION OF THE TISSUE PAD, A PROBABLE CAUSE FOR THIS DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. 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 RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. THE CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU, CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. BATCH # L90K30. METHOD, RESULT AND CONCLUSION CODES: NI. (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WHITE TISSUE PAD FELL OFF. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS. THE BROKEN PIECE WAS DISPOSED OF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576806 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L90K30

    Patients

    Seq Age Sex Outcome Treatment
    1