BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO, OUS

    MDR report key: 3577315 · Received November 14, 2013

    Report

    Report Number
    2242352-2013-01552
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 23, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    2242352-10/28/13-002R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. THE JAW BOOTS DISPLAYED EVIDENCE OF HEAT RELATED DAMAGE CONSISTENT WITH ACTIVATION OF THE DEVICE WHILE THE JAWS ARE IN DIRECT CONTACT. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST, IT REMAINED ACTIVATED WHEN THE TOGGLE SWITCH WAS RELEASED. THE HANDLE ON THE DEVICE WAS OPEN TO VERIFY CONNECTIONS; UNDER MAGNIFICATION, SOLDERING FLUX WAS OBSERVED ON THE SWITCH BODY, LEVER AND ACTUATOR OF THE MICRO-SWITCH. THE SOLDERING FLUX CAUSED THE MICRO-SWITCH ACTUATOR TO BE STUCK IN THE ON POSITION. THE FOLLOWING CORRECTIVE ACTION HAS BEEN TAKEN TO ADDRESS THE SOLDER FLUX ISSUE: MAQUET HAS REVISED THE WORK INSTRUCTION FOR THE SOLDERING PROCESS (B)(4)/ HANDLE ASSEMBLY (B)(4) TO ADD ENHANCED VISUAL INSPECTION TO THE SOLDERING POINTS AND THE SWITCH CONTAMINATION WITH FLUX. MAQUET CARDIOVASCULAR LLC HAS INITIATED RECALL (B)(4) TO ADDRESS THIS FAILURE MODE. THE FDA (B)(4) DISTRICT RECALL COORDINATOR HAS BEEN ADVISED. A NOTIFICATION LETTER HAS BEEN SENT TO THIS CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO, OUS ACTIVATED BEFORE THE TOGGLE SWITCH WAS ENGAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591265 VASOVIEW HEMOPRO, OUS ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC VH-3000-W 25077051

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR