BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3936084 · Received June 23, 2014

    Report

    Report Number
    2242352-2014-00708
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION IDENTIFIED THAT THE SILICONE BOOT ON THE COLD SIDE HAD SEPARATED FROM THE JAW. THE MISSING PIECE OF THE BOOT WAS RETURNED WITH THE DEVICE. SOME HEAT DAMAGE WAS OBSERVED ON THE SILICONE COLD JAW WIRE CONTACT SURFACE. ADDITIONALLY, THE SILICONE BOOTS ON THE HOT AND COLD JAWS HAD AN AREA OF PHYSICAL DAMAGE WITH ROUGH EDGES. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DAMAGE SEEN AFTER AN IMPROPER INSERTION OF THE TOOL INTO THE CANNULA. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, PART OF THE JAW ON THE VASO VIEW HEMOPRO FELL AND BROKE OFF INTO THE PT. IT WAS RETRIEVED THROUGH THE ORIGINAL INCISION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367041 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25096016

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other