BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2202662 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02773
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SUTURE CAPTURING DEVICE WAS USED WITH A REPLIFORM GRAFT DURING A POSTERIOR BILATERAL SACROSPINOUS FIXATION PROCEDURE IN 2004 (EXACT DATE UNKNOWN). THERE WERE NO REPORTED PATIENT COMPLICATIONS DURING THIS PROCEDURE. THE PATIENT'S CURRENT AGE IS REPORTEDLY ABOUT (B)(6) YEARS. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT PRESENTED WITH PELVIC PAIN. THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPIC PROCEDURE AND REMOVED ADHESIONS THAT WERE RELATED TO THE PAIN. THE PATIENT HAD AN MRI SCAN WHICH REVEALED A SEMICIRCULAR OBJECT NEAR THE ISCHIAL SPINE ON THE PATIENT'S LEFT SIDE. THE PHYSICIAN BELIEVED THE OBJECT MIGHT BE THE NEEDLE CARRIER FROM A CAPIO DEVICE. THE PATIENT HAS NOT HAD ANY OTHER PROBLEMS RELATED TO THE SACROSPINOUS FIXATION PROCEDURE. THE PATIENT HAD A VAGINAL DISSECTION, BUT THE PHYSICIANS WERE UNABLE TO FEEL OR FIND THE OBJECT. THE OBJECT WAS NOT IDENTIFIED OR REMOVED FROM THE PATIENT. ADDITIONALLY, THE NEEDLE COUNT AT THE END OF THE INITIAL PROCEDURE IN 2004 WAS REPORTED TO BE CORRECT. THE EXACT DATE OF ONSET OF THE PELVIC PAIN AND SUBSEQUENT TESTS ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY "DOING WELL".

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO REMOVE THE OBJECT (EXACT DATE UNKNOWN) IN THE PATIENT BUT WAS NOT ABLE TO ISOLATE AND SAFELY REMOVE THE OBJECT. THE PHYSICIAN STILL BELIEVES THE OBJECT TO BE THE CURVED NEEDLE CARRIER OF A CAPIO DEVICE BECAUSE ALL NEEDLE COUNTS WERE CORRECT POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R REPLIFORM GRAFT