BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1916695 · Received December 7, 2010

    Report

    Report Number
    3005099803-2010-05026
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, SHE IS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4) - THE REPORTED ISSUE OF SUTURE DETACHMENT. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL PROLAPSE REPAIR PROCEDURE USING A CAPIO STANDARD SUTURE CAPTURING DEVICE, THE PHYSICIAN SUCCESSFULLY USED THE CAPIO DEVICE TO PLACE TWO CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) INSIDE THE PATIENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO THROW A THIRD SUTURE THROUGH THE PATIENT'S TISSUE, LESS THAN 1 CENTIMETER OF THE SUTURE (WITH THE NEEDLE AT THE END), DETACHED INSIDE THE PATIENT. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE SUTURE AS HE WAS CONCERNED AT CAUSING TRAUMA BY ATTEMPTING TO REMOVE THE SUTURE FROM INSIDE THE PATIENT AND DID NOT BELIEVE THAT "THE SUTURE POSED ANY SIGNIFICANT RISK TO THE PATIENT." THERE WAS REPORTEDLY NO INDICATION OF ANY PROBLEM WITH EITHER THE CAPIO DEVICE OR THE CAPIO SUTURE DURING INSPECTION, PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO STANDARD SUTURE CAPTURING DEVICE, WITHOUT ANY FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY IN "GOOD" CONDITION POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL PROLAPSE REPAIR PROCEDURE USING A CAPIO STANDARD SUTURE CAPTURING DEVICE, THE PHYSICIAN SUCCESSFULLY USED THE CAPIO DEVICE TO PLACE TWO CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) INSIDE THE PATIENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO THROW A THIRD SUTURE THROUGH THE PATIENT'S TISSUE, LESS THAN 1 CENTIMETER OF THE SUTURE (WITH THE NEEDLE AT THE END), DETACHED INSIDE THE PATIENT. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE SUTURE AS HE WAS CONCERNED AT CAUSING TRAUMA BY ATTEMPTING TO REMOVE THE SUTURE FROM INSIDE THE PATIENT AND DID NOT BELIEVE THAT "[THE SUTURE] POSED ANY SIGNIFICANT RISK TO THE PATIENT." THERE WAS REPORTEDLY NO INDICATION OF ANY PROBLEM WITH EITHER THE CAPIO DEVICE OR THE CAPIO SUTURE DURING INSPECTION, PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO STANDARD SUTURE CAPTURING DEVICE, WITHOUT ANY FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY IN "GOOD" CONDITION 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 M0068312321 11555732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CAPIO SUTURE (TELEFLEX MEDICAL INC.)