BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD? LITE

    MDR report key: 3901107 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02347
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS. THE PROBLEM OF SUTURE DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED UPHOLD (TM) LITE WITH CAPIO SLIM DEVICE REVEALED THAT THE BLUE WITH WHITE STRIPE DILATOR IS BROKEN, THE SUTURE AND DART ARE MISSING AND NOT RETURNED. THE BLUE DILATOR IS BROKEN, THE SUTURE AND DART ARE MISSING AND NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM WAS USED DURING A PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE BUT NOTHING WAS LEFT INSIDE THE PATIENT. A NEW UPHOLD LITE WITH CAPIO SLIM WAS OPENED AND USED TO FINISH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM WAS USED DURING A PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE BUT NOTHING WAS LEFT INSIDE THE PATIENT. A NEW UPHOLD LITE WITH CAPIO SLIM WAS OPENED AND USED TO FINISH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378943 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170 ML00001463

    Patients

    Seq Age Sex Outcome Treatment
    1