BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ACE+ SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 6085810 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00040
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 3, 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
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO MEDLINE RENEWAL, HOWEVER AN UNUSED, REPROCESSED HAR36M FROM THE SAME LOT THAT WAS STILL SEALED IN THE ORIGINAL MEDLINE RENEWAL PACKAGE WAS RETURNED FOR EVALUATION. OUR INVESTIGATION INCLUDED BOTH AN INSPECTION OF THE RETURNED DEVICE, AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). DURING THE INVESTIGATION, THE DEVICE WAS SUBJECTED TO ALL INSPECTION AND TESTING PROCEDURES, AND AS A RESULT, MET ALL ACCEPTANCE CRITERIA. IN ADDITION, OUR REVIEW OF THE DHR RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. THE CUSTOMER CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, DUE TO THE REPORTED DELAY IN THE PROCEDURE TO OBTAIN A NEW DEVICE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. H3 OTHER TEXT : ANOTHER DEVICE FROM SAME LOT EVALUATED

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED ETHICON HARMONIC ACE+ LAPAROSCOPIC SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M, DID NOT CONNECT PROPERLY TO THE GENERATOR, AND THAT THE DEVICE WOULD NOT ACTIVATE DURING USE. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737251 MEDLINE RENEWAL REPROCESSED ACE+ SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY ULTRASONIC SCALPEL, HARMONIC SCALPEL NLQ MEDLINE RENEWAL HAR36M 307295 10888277408708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention