BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8880505 · Received August 9, 2019

    Report

    Report Number
    2242352-2019-00920
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B1 CORRECTION: "ADVERSE EVENT & PRODUCT PROBLEM" IS SELECTED. "OTHER" IS SELECTED FOR 'OUTCOME ATTRIBUTED TO AE" H1 CORRECTION: "SERIOUS INJURY" IS SELECTED. INTERNAL COMPLAINT NUMBER: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/11/2019. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. A VISUAL INSPECTION WAS CONDUCTED OF THE ACTUAL DEVICE RETURNED AS WELL AS THE PHOTOGRAPH THAT WAS PROVIDED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE BASE OF THE JAWS. THE SILICONE INSULATION ON THE COLD JAW WAS OBSERVED TO BE PEELED OFF FROM THE MIDDLE OF THE COLD JAW TO THE TIP, EXPOSING THE METAL PORTION OF THE COLD JAW. THE DETACHED SILICONE WAS NOT RETURNED FOR EVALUATION. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW AT THE CENTER OF THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP. NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURES "PEELED JAW" AND " MATERIAL TWISTED/BENT WIRE" WERE BOTH CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO. TIP BROKE. 3 PIECES OF THE JAW WERE REMOVED. FIRST PIECE THAT BROKE WAS RETRIEVED WITH THE JAWS OF THE PRODUCT, IT CRACKED/BROKE AGAIN AND THEY OPENED A NEW EVH KIT AND USED IT TO REMOVE THE REMAINING TWO PIECES AND 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. TIP BROKE. 3 PIECES OF THE JAW WERE REMOVED. FIRST PIECE THAT BROKE WAS RETRIEVED WITH THE JAWS OF THE PRODUCT, IT CRACKED/BROKE AGAIN AND THEY OPENED A NEW EVH KIT AND USED IT TO REMOVE THE REMAINING TWO PIECES AND TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674579 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146630

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other