BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR

    MDR report key: 6089361 · Received November 9, 2016

    Report

    Report Number
    3032391-2016-00025
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    August 29, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    NLM
    PMA / PMN Number
    K012644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION. WE CONFIRMED THAT THE TROCAR IN QUESTION WAS REPROCESSED ONE TIME, AND WE CONFIRMED THE SUTURE STAYS LOCATED ON THE ADJUSTABLE FIXATION PLUG WERE BROKEN UPON RECEIPT. THE DEVICE WENT THROUGH A THOROUGH INSPECTION AND OTHER THAN THE SUTURE STAYS THAT BROKE OFF THE DEVICE, ALL OTHER DEVICE COMPONENTS MET ESTABLISHED INSPECTION CRITERIA PRIOR TO INITIAL PACKAGE AND RELEASE UNFORTUNATELY, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ACTUAL ROOT CAUSE OF THE FAILURE. MEDLINE RENEWAL CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE, PROCEDURAL DELAY, OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE FAILURE. THEREFORE IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE SUTURE STAYS LOCATED ON THE ADJUSTABLE FIXATION PLUG OF A REPROCESSED ETHICON XCEL TROCAR, MODEL H12LP, DETACHED DURING USE. THE COMPONENT IS USED TO SECURE SUTURE DURING THE COURSE OF THE SURGERY. 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
    741078 MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR LAPAROSCOPIC TROCAR NLM MEDLINE RENEWAL H12LP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention