BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 9040340 · Received September 13, 2019

    Report

    Report Number
    2242352-2019-01028
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    July 19, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: WEIGHT; FROM KGS TO LBS. TRACKWISE ID # (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED: TO "BREAK". TRACKWISE ID # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/26/219. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. BLOOD WAS OBSERVED ON THE DISTAL END OF THE CANNULA, AS WELL AS ON THE CANNULA HANDLE. THE C-RING WAS OBSERVED TO BE INTACT, HOWEVER THE SCOPE WASH TUBING WAS OBSERVED TO BE CUT AWAY FROM THE BODY OF THE C-RING. THE END OF THE SCOPE WASH TUBING WAS OBSERVED TO BE MELTED. THE SCOPE WASH TUBING AND THE C-RING REMAINED ATTACHED TO THE CANNULA DUE THE PRESENCE OF A RETENTION RIB. NO OTHER VISUAL DEFECTS WERE OBSERVED. . BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED FAILURE MODE "BREAK; C-RING CUT¿ WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 BROKE IN THE PT. ONE OF THE METAL ARMS BROKE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 BROKE IN THE PT. ONE OF THE METAL ARMS BROKE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 BROKE IN THE PT. ONE OF THE METAL ARMS BROKE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817855 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25144436

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention