BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1720040 · Received June 11, 2010

    Report

    Report Number
    3005099803-2010-02437
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT INDICATED THAT THE DEVICE WAS CONTAMINATED AND WILL NOT BE RETURNED FOR EVALUATION, IT WAS REPORTED THAT WHEN THE DEVICE WAS EVALUATED BY THE TERRITORY MANAGER WHEN HE WAS INFORMED OF THE INCIDENT ON (B)(6) 2010, THE DEVICE WAS ABLE TO LOAD AND THROW A SUTURE NORMALLY AND REPORTEDLY "WORKED FINE." THE COMPLAINT REGARDING THE CAGE FAILING TO CATCH THE NEEDLE WAS NOT CONFIRMED. THE REPORTED ISSUE OF THE CAPIO DEVICE NOT BEING LABELED WITH AN EXPIRY DATE WAS ALSO NOT CONFIRMED. A REVIEW OF THE SHOP FLOOR PAPERWORK INDICATED THAT ALL LABELS ISSUED TO LOT# 12693441 WERE LABELED WITH AN EXPIRATION DATE OF JUNE 2012. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED NO ISSUES OR ANOMALIES, NO NON-CONFORMANCE EVENTS WERE GENERATED AND NO COMPONENT ISSUES AT THE TIME OF MANUFACTURE OF THIS LOT RELEVANT TO THIS EVENT, WERE IDENTIFIED. ALL RECORDS INDICATED THAT THE CAPIO DEVICE WAS FINAL INSPECTION TESTED AT THE BOSTON SCIENTIFIC (B)(4) FACILITY AND DETERMINED TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A SACROSPINOUS FIXATION PROCEDURE TO REPAIR VAGINAL PROLAPSE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NURSE SUCCESSFULLY LOADED THE SIZE 0 CAPIO SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORPORATION) INTO THE CAPIO DEVICE. HOWEVER, WHEN THE SUTURE WAS THROWN, THE CAPIO CAGE FAILED TO CATCH THE NEEDLE ATTACHED TO THE SUTURE. THE CAPIO DEVICE REPORTEDLY DID NOT COME IN CONTACT WITH THE PATIENT. IT WAS ALSO REPORTED THAT THE CAPIO DEVICE WAS NOT LABELED WITH AN EXPIRY DATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY DOING "ABSOLUTELY FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 12693441

    Patients

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