BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2900442 · Received January 7, 2013

    Report

    Report Number
    3005099803-2013-00053
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SUTURE CAPTURING DEVICE (EXACT TYPE UNKNOWN) WAS USED DURING SACROSPINOUS LIGAMENT FIXATION PROCEDURE. WHEN THE PHYSICIAN PULLED ON THE SUTURE, IT BROKE AND DETACHED FROM THE NEEDLE. REPORTEDLY, THE PHYSICIAN RETRIEVED THE DETACHED NEEDLE WITH FORCEPS. THE PHYSICIAN WAS UNABLE TO THE PROCEDURE BECAUSE ANOTHER OF THE SAME CAPIO SUTURE CAPTURING DEVICE WAS UNAVAILABLE. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7053 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention POLYPROPYLENE 48IN SIZE 0 SUTURE