BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8944309 · Received August 29, 2019

    Report

    Report Number
    2242352-2019-00991
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DHR FOR THE ANALYZED FAILURES "MATERIAL TWISTED/BENT; WIRE" AND "PEELED JAW" WAS REVIEWED. THE VENDORS CERTIFY THAT ALL THE DEVICE LOTS MANUFACTURED CONFORMS TO ALL THE APPLICABLE PRODUCT SPECIFICATIONS. THERE WERE NO NON-CONFORMITIES OBSERVED. THE DEVICE WAS RETURNED FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 11/19/2019. THE HARVESTING TOOL AND CANNULA WERE RETURNED. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON THE SIDE OF THE COLD JAW WAS OBSERVED TO BE PEELED AND CRACKED, EXPOSING THE METAL PORTION OF THE COLD JAW. NO OTHER VISUAL DEFECTS WERE OBSERVED ON THE HARVESTING TOOL. THE CANNULA WAS EVALUATED. THERE WERE NO VISUAL DEFECTS ON THE CANNULA. THE DEVICE WAS EVALUATED FOR ELECTRICAL FUNCTION. A PRE-CAUTERY TEST AS WAS PERFORMED PER THE INSTRUCTION FOR USE WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE PRE-CAUTERY TEST WAS REPEATED 10 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH NO OBSERVED FAILURE. THE HANDLE WAS OPENED TO EVALUATE THE INTERNAL COMPONENTS. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. THE SWITCH WAS EXAMINED UNDER MICROSCOPY. NO RESIDUE OR CONTAMINATION WAS SEEN ON THE SWITCH. WE WERE UNABLE TO OBSERVE ANY ELECTRICAL ISSUES OR FAILURE TO ENERGIZE FOR THE COMPLAINT UNIT DURING OUR TESTING. BASED ON THE CONDITION OF THE DEVICE AS RETURNED, THE SPECIFIC FAILURE MODE COULD NOT BE IDENTIFIED AS NO SPECIFIC FAILURE MODE WAS REPORTED. HOWEVER, THE ANALYZED FAILURE MODES ¿MATERIAL TWISTED/BENT; WIRE" AND "PEELED JAW" WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT A DEFECTIVE VASOVIEW HEMOPRO USED FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE WAS SENT TO INVENTORY WITHOUT ANY FURTHER INFORMATION. NO PATIENT INVOLVEMENT.

    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 A DEFECTIVE VASOVIEW HEMOPRO USED FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE WAS SENT TO INVENTORY WITHOUT ANY FURTHER INFORMATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737891 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25145626

    Patients

    Seq Age Sex Outcome Treatment
    1