BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3142848 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02742
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 22, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE (A) RECEIVED IN GOOD CONDITION. DEVICE RECEIVED IN GOOD CONDITION. WHEN THE DEVICE WAS CONNECTED TO THE EEPROM READER, THE EEPROM WAS FOUND NOT TO BE PROGRAMMED (INSTRUMENT EEPROM READ VERIFICATION MISMATCH). THE DEVICE WAS ALSO CONNECTED TO A TEST HANDPIECE AND THE GENERATOR IMMEDIATELY DISPLAYED THE "REPLACE INSTRUMENT" SCREEN AND THE DEVICE COULD NOT BE ACTIVATED FOR FURTHER FUNCTIONAL TESTING. DEVICE (B) WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND IT DID ACTIVATE DURING FUNCTIONAL TESTING. THE BLADE WAS NOT BROKEN OFF AS REPORTED. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AVOID ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO PREVENT DAMAGE TO THE TISSUE PAD. DEVICE B ADDITIONAL INFORMATION: BATCH # K9078H, EXPIRATION DATE: 12/31/2017, MANUFACTURING DATE: 1/31/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT MEET THE CUSTOMER¿S EXPECTATIONS. THE DEVICES WERE LEFT IN THE OFFICE WITH NOTES. ONE NOTE SAID "DEVICE WOULD NOT ACTIVATE" AND THE OTHER SAID "TIP BROKE OFF DURING CASE". THERE IS NO ADDITIONAL INFO ABOUT THESE TWO DEVICES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. UNKNOWN HOW CASE WAS COMPLETED. TWO DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244800 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE