BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ACE+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 6088191 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00030
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 28, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    NLQ
    UDI-DI
    10888277408708
    PMA / PMN Number
    K151405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND WE CONFIRMED THAT IT WAS A MEDLINE RENEWAL REPROCESSED ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M. WE PERFORMED A THOROUGH INSPECTION AND INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION CONFIRMED THAT THE BLACK PART OF THE TISSUE PAD LOCATED ON THE DISTAL TIP OF THE DEVICE HAD DETACHED, CONFIRMING THE INITIAL REPORT. HOWEVER, MEDLINE RENEWAL WAS UNABLE TO RE-CREATE THE ERROR CODE TO "RELAX PRESSURE" DURING OUR INVESTIGATION. WE CONCLUDED THAT THE ROOT CAUSE OF BLACK PAD DETACHMENT FROM THE DEVICE WAS ADHESIVE FAILURE. THE ETHICON GEN 11 GENERATOR MAY DISPLAY THE "RELAX PRESSURE" ERROR CODE IF TOO MUCH TISSUE IS PLACED BETWEEN THE JAWS TO ALLOW THE DEVICE TO OPERATE PROPERLY. THE CUSTOMER CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, DUE TO THE DETACHED COMPONENT AND THE REPORTED DELAY IN THE PROCEDURE REQUIRED TO OBTAIN A NEW DEVICE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE GENERATOR INITIATED AN ERROR CODE TO "RELAX PRESSURE" DURING THE USE OF A REPROCESSED ETHICON HARMONIC ACE+ LAPAROSCOPIC SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M. THEN PART OF THE TISSUE PAD LOCATED ON THE DISTAL TIP DETACHED FROM THE DEVICE AND WAS RETRIEVED BY THE SURGEON. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737608 MEDLINE RENEWAL REPROCESSED ACE+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY HARMONIC SCALPEL NLQ MEDLINE RENEWAL HAR36M 305527 10888277408708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention