BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE SURGIPRO 6/0

    MDR report key: 73348 · Received February 27, 1997

    Report

    Report Number
    2647580-1997-00185
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    January 31, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1. THE USER FACILITY STATED THAT THE BREAKAGE OCCURRED WHEN THE SURGEON WAS COMPLETING A RUNNING STITCH. THE USER FACILITY WAS UNABLE TO PROVIDE ANY FURTHER INFO REGARDING RELEVANT EVENTS PRIOR TO OR SUBSEQUENT TO THE ACTUAL INCIDENT. 2. THE SAMPLES INVOLVED IN THE EVENT WERE DISCARDED BY THE USER FACILITY; HOWEVER, TWENTY FIVE SEALED SAMPLES WERE RETURNED FOR EVALUATION AT CO'S FACILITY. THE SAMPLES WERE TESTED FOR TENSILE STRENGTH VALUES AND WERE FOUND TO MEET AND/OR EXCEED THE USP AVERAGE MINIMUM AND CO INTERNAL QUALITY STANDARD AVERAGE MINIMUM (WHICH EXCEEDS THE USP STANDARD). 3. AN EVALUATION OF THE INCIDENT WAS NOT PROVIDED BY THE USER FACILITY OR ANY HEALTHCARE PROFESSIONAL INVOLVED WITH THESE EVENTS. 4. EVENT FREQUENCY AND SEVERITY ARE UNK. 5. CO COULD NOT DETERMINE IF THE EVENT WAS ATTRIBUTED TO THE DEVICE AS THE ACTUAL SUTURE USED DURING THE EVENT WAS UNAVAILABLE FOR EVALUATION AND NO DISCREPANCIES WERE FOUND IN THE SEALED REP SAMPLES TESTED AT CO'S FACILITY.

    Description of Event or Problem · 1

    DURING A CAROTID PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER PRODUCT. THE HOSPITAL REPORTED THAT NO PATIENT INJURY HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE SURGIPRO 6/0 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA T6J116KW

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN