BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 18924147 · Received March 18, 2024

    Report

    Report Number
    2242352-2024-00258
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 27, 2024
    Report Date
    April 12, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID# (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 03/15/2024. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CLEAR HOT JAW INSULATION. THE CLEAR COLD JAW INSULATION WAS OBSERVED TO BE PEELED ON THE TIP OF THE COLD JAW, EXPOSING THE METAL COLD JAW TIP. NO OTHER VISUAL DEFECTS WERE OBSERVED. AN INVESTIGATION WAS CONDUCTED ON 03/19/2024. A VISUAL INSPECTION WAS CONDUCTED. BOTH THE HARVESTING DEVICE AND CANNULA WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE HARVESTING DEVICE WAS RETURNED INSIDE THE SCOPE PORT ON THE CANNULA. A MECHANICAL EVALUATION WAS CONDUCTED. THE HARVESTING DEVICE WAS REMOVED FROM THE SCOPE PORT OF THE CANNULA WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CANNULA OR THE INTACT C-RING. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CLEAR HOT JAW INSULATION. THE CLEAR COLD JAW INSULATION ON THE HARVESTING JAWS WAS OBSERVED TO BE PEELED BACK, EXPOSING THE METAL COLD JAW TIP. NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE PHOTOGRAPHIC EVALUATION AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "PEELED; DELAMINATED; JAW" WAS CONFIRMED. THE LOT # 3000368360 HISTORY RECORD REVIEW WAS COMPLETED. 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

    RELATED TO 992722; THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 INSULATION WAS COMING OFF OF THE JAWS RIGHT OUT OF THE BOX. PER PHOTO PROVIDED BY THE COMPLAINANT, THE SILICONE AT THE TIP OF THE JAWS HAS SPLIT, AND IS PEELING FROM THE JAWS. THEY DID NOT USE THIS KIT AND OPENED A NEW ONE. SLIGHT DELAY TO OPEN A NEW KIT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956072 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000368360 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male