BEUDAMED
    FDA Adverse Event Injury Summary report: N

    173016 @ENDO STITCH 10 MM SUTURING DEVIC

    MDR report key: 12861439 · Received November 23, 2021

    Report

    Report Number
    3032391-2021-00018
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    HCF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHILE SEWING THE VAGINAL CUFF, AFTER A LAP HYSTERECTOMY, A PIECE OF THE NEEDLE ON THE ENDOSTICH BROKE AND WAS NOT ABLE TO BE LOCATED AND REMOVED. AN X-RAY WAS TAKEN AND THE PIECE WAS FOUND BUT WAS NOT ABLE TO BE REMOVED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE ON THE ENDOSTICH BROKE DURING USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763275 173016 @ENDO STITCH 10 MM SUTURING DEVIC HCF MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other