BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 11766855 · Received May 3, 2021

    Report

    Report Number
    2242352-2021-00332
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25155427, 25155932, AND 25156448 THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT/AWARE DATE. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 TIP OF THE CAUTERY WAS BEING CLEANED OFF OUTSIDE THE PATIENT'S BODY WITH A LAP SPONGE BY A SURGICAL TECH, AND THE TECH NOTICED THE OUTSIDE PART OF THE TIP OF THE JAW CAME OFF IN THE SPONGE. IT'S UNKNOWN WHICH PART (SILICONE OR METAL WIRE) CAME OFF THE JAWS TIP. NO HARM TO THE PATIENT. ANOTHER HEMOPRO 2 VH-4000 KIT WAS OPENED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 TIP OF THE CAUTERY WAS BEING CLEANED OFF OUTSIDE THE PATIENT'S BODY WITH A LAP SPONGE BY A SURGICAL TECH, AND THE TECH NOTICED THE OUTSIDE PART OF THE TIP OF THE JAW CAME OFF IN THE SPONGE. IT'S UNKNOWN WHICH PART (SILICONE OR METAL WIRE) CAME OFF THE JAWS TIP. NO HARM TO THE PATIENT. ANOTHER HEMOPRO 2 VH-4000 KIT WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662824 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR