BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR

    MDR report key: 6088130 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00011
    Event Type
    Malfunction
    Date Received
    November 8, 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
    CT, US
    Reporter Occupation
    NURSE

    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 THAT THE SUTURE STAY LOCATED ON THE ADJUSTABLE FIXATION PLUG WAS MISSING UPON RECEIPT. THE DEVICE UNDERWENT A THOROUGH INSPECTION, AND OTHER THAN THE MISSING SUTURE STAY, ALL OTHER DEVICE COMPONENTS MET ESTABLISHED INSPECTION CRITERIA. IN ADDITION, WE PERFORMED A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 303905, AND WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET ALL THE INSPECTION REQUIREMENTS PRIOR TO INITIAL PACKAGING 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. HOWEVER, IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT ONE OF 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 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
    737189 MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR LAPAROSCOPIC TROCAR, REPROCESSED NLM MEDLINE RENEWAL H12LP 303905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention