BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF SURGICAL

    MDR report key: 7136251 · Received December 20, 2017

    Report

    Report Number
    3005883396-2017-05116
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 20, 2017
    Manufacturer
    DEVON INDUSTRIES, INC
    Product Code
    LWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE WAS REQUESTED BUT THE CUSTOMER HAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE INITIAL PROCEDURE (ABDOMINAL AORTIC ANEURYSM) ON (B)(6). FOUR COTTON GAUZE DEVICES INTENTIONALLY LEFT IN THE PATIENT AND WERE TO BE REMOVED AT THE FOLLOW-UP SURGERY ON (B)(6). THE SITE WAS LEFT OPEN UNTIL THE FOLLOW-UP SURGERY WAS TO BE PERFORMED ON THE (B)(6). FOLLOW-UP PROCEDURE ON (B)(6) COMPLETED BUT TAGS WERE NOT REMOVED. ACCOUNT CLAIMED THAT THE CONSOLE WAS USED WITH THE WAND TO CHECK FOR RETAINED COTTON DEVICES PRIOR TO CLOSURE AND DID NOT INDICATE RETAINED TAGS. ONLY THE BLAIR PORT WAND (01-0049) AND THE MODEL 200E ¿ E+ BOOST CONSOLE (01-0030) WERE IDENTIFIED AS BEING EMPLOYED DURING THE (B)(6) PROCEDURE. THE MAT WAS IDENTIFIED AS NOT BEING EMPLOYED DURING THIS PROCEDURE. PATIENT RETURNED TO THE HOSPITAL ON (B)(6)TACHYCARDIA AND FEVER. RETAINED COTTON DEVICES IDENTIFIED WITH CT SCAN AS WELL AS THE USE OF A RF ASSURE SYSTEM. RETAINED COTTON REMOVED BY SURGICAL PROCEDURE ON (B)(6). ALL RETAINED COTTON DEVICES (4) WERE SCRAPPED. SUSPECT RF ASSURE SYSTEM WAS QUARANTINED AND TESTED IN AN OFFICE AREA EMPLOYING NEW TAGS WITH ACCEPTABLE DETECTION RESULTS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913261 RF SURGICAL COUNTER, SPONGE, SURGICAL LWH DEVON INDUSTRIES, INC UNKNOWN LAP SPONGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R