BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR

    MDR report key: 6088136 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00013
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    June 30, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    NLM
    PMA / PMN Number
    K012644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. THE REPROCESSED ETHICON H12LP WAS REPROCESSED ONE TIME BY MEDLINE RENEWAL. UPON RECEIPT, WE CONFIRMED THAT THE LOCKING MECHANISM LOCATED ON THE ADJUSTABLE FIXATION PLUG WAS BROKEN. ALL OTHER COMPONENTS MET ESTABLISHED INSPECTION CRITERIA. IN ADDITION, WE PERFORMED A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 302057. WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AND THAT THE DEVICE MET ALL THE INSPECTION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. UNFORTUNATELY, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. EVEN THOUGH MEDLINE RENEWAL CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE, PROCEDURAL DELAY, OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE FAILURE, IN AN ABUNDANCE OF CAUTION MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE LOCK LOCATED ON THE ADJUSTABLE FIXATION PLUG OF A REPROCESSED ETHICON XCEL TROCAR, MODEL H12LP BROKE WHILE THE SCRUB TECH TRIED TO LOCK IT. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE THERE WAS NO ADVERSE PATIENT CONSEQUENCE, PROCEDURAL DELAY OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738244 MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR LAPAROSCOPIC/ENDOSCOPIC TROCAR AND CANNULA NLM MEDLINE RENEWAL H12LP 302057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention