BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 9736187 · Received February 20, 2020

    Report

    Report Number
    2242352-2020-00170
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: G-4, G-7, H-2, H-3, H-6, H-10. D4 CORRECTION: LOT NUMBER IS 251489945. D4 CORRECTION: EXPIRATION DATE IS 11/14/2020. H4 CORRECTION: MANUFACTURING DATE IS 11/15/2019. INTERNAL COMPLAINT NUMBER: TW # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 17FEB2020. AN INVESTIGATION WAS CONDUCTED ON 27FEB2020. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY AT THE CENTER OF THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT DID PRODUCE VISIBLE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES BUT SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE PRE-CAUTERY TEST WAS REPEATED 5 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH THE NO FAILURE OBSERVED. THE TOOL HANDLE WAS OPENED TO EVALUATE THE INTERNAL SWITCH. THE SWITCH WAS EXAMINED UNDER MICROSCOPIC CAMERA. NO RESIDUE OR CONTAMINATION WAS SEEN ON THE SWITCH. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED COMPLAINT FOR FAILURE "FAILURE TO DELIVER ENERGY" WAS NOT CONFIRMED BUT WAS CONFIRMED FOR THE ANALYZED FAILURE "MATERIAL TWISTED/BENT WIRE".

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO WOULD NOT ACTIVATE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID #(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 WOULD NOT ACTIVATE. 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
    199168 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25148995

    Patients

    Seq Age Sex Outcome Treatment
    1