BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5207603 · Received November 6, 2015

    Report

    Report Number
    2242352-2015-01244
    Event Type
    Malfunction
    Date Received
    November 6, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. EVIDENCE OF BLOOD AND SIGNS OF SOME CLINICAL USE WERE OBSERVED ON THE CANNULA. THE SCOPE WASH TUBING WAS KINKED AND WAS TRANSECTED IMMEDIATELY BELOW THE ADHESIVE JOINT TO THE C-RING. ADHESIVE WAS OBSERVED AT THE JOINT. THE SCOPE WASH TUBING REMAINED ATTACHED TO THE CANNULA DUE THE PRESENCE OF A RETENTION RIB. THE BOND BETWEEN THE WIRE AND THE C-RING REMAINED INTACT. DURING VISUAL INSPECTION, COMPRESSED AREAS OF DEFORMATION AND BENDING WERE OBSERVED. THE TRANSECTED SURFACES EXHIBITED TEARING AND PLASTIC DEFORMATION CONSISTENT WITH BENDING AND PULLING WHICH RESULTED IN THE TUBING BREAK. THE TUBING WAS PULLED FORWARD IN THE DIRECTION OF TOOL TRAVEL AND DISPLAYED KINKS LOCATED IN THE TOOL PATH. BASED ON THE CONDITION OF THE DEVICE AS RETURNED, WE WERE ABLE TO CONFIRM THE REPORTED COMPLAINT FOR ¿C-RING ASSEMBLY/SCOPE WASH TUBING TRANSECTED BY CAUTERY TOOL¿. THE ROOT CAUSE IS ENGAGEMENT OF THE SCOPE WASH TUBING WITH THE FORCEPS ON THE CAUTERY TOOL DURING USE. THE ROOT CAUSE IS ADDRESSED IN THE INSTRUCTIONS FOR USE. THE IFU PROVIDES INSTRUCTION TO THE USER; "TAKE CARE TO AVOID ENGAGING THE COMPONENTS OF THE C-RING ASSEMBLY WITH THE FORCEPS. DOING SO MAY DAMAGE PORTIONS OF THE C-RING ASSEMBLY CAUSING THE COMPONENTS TO SEPARATE FROM THE ASSEMBLY AND FALL INTO THE BODY." THIS DEVICE LOT HAS BEEN MANUFACTURED WITH THE ADDITION OF THE RETENTION RIB TO PREVENT THE TRANSECTED PORTION OF THE SCOPE WASH TUBING ON THE C-RING ASSEMBLY FROM DISLODGING INTO THE PATIENT. (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. EVIDENCE OF BLOOD AND SIGNS OF SOME CLINICAL USE WERE OBSERVED ON THE CANNULA. THE SCOPE WASH TUBING WAS KINKED AND WAS TRANSECTED IMMEDIATELY BELOW THE ADHESIVE JOINT TO THE C-RING. ADHESIVE WAS OBSERVED AT THE JOINT. THE SCOPE WASH TUBING REMAINED ATTACHED TO THE CANNULA DUE THE PRESENCE OF A RETENTION RIB. THE BOND BETWEEN THE WIRE AND THE C-RING REMAINED INTACT. DURING VISUAL INSPECTION, COMPRESSED AREAS OF DEFORMATION AND BENDING WERE OBSERVED. THE TRANSECTED SURFACES EXHIBITED TEARING AND PLASTIC DEFORMATION CONSISTENT WITH BENDING AND PULLING WHICH RESULTED IN THE TUBING BREAK. THE TUBING WAS PULLED FORWARD IN THE DIRECTION OF TOOL TRAVEL AND DISPLAYED KINKS LOCATED IN THE TOOL PATH. BASED ON THE CONDITION OF THE DEVICE AS RETURNED, WE WERE ABLE TO CONFIRM THE REPORTED COMPLAINT FOR ¿C-RING ASSEMBLY/SCOPE WASH TUBING TRANSECTED BY CAUTERY TOOL¿. THE ROOT CAUSE IS ENGAGEMENT OF THE C-RING WITH THE FORCEPS ON THE CAUTERY TOOL DURING USE. THE ROOT CAUSE IS ADDRESSED IN THE INSTRUCTIONS FOR USE. THE IFU PROVIDES INSTRUCTION TO THE USER; "TAKE CARE TO AVOID ENGAGING THE COMPONENTS OF THE C-RING ASSEMBLY WITH THE FORCEPS. DOING SO MAY DAMAGE PORTIONS OF THE C-RING ASSEMBLY CAUSING THE COMPONENTS TO SEPARATE FROM THE ASSEMBLY AND FALL INTO THE BODY." THIS DEVICE LOT HAS BEEN MANUFACTURED WITH THE ADDITION OF THE RETENTION RIB TO PREVENT THE TRANSECTED PORTION OF THE SCOPE WASH TUBING ON THE C-RING ASSEMBLY FROM DISLODGING INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    NOVEMBER 05, 2015 06:12 PM (GMT-5:00) ADDED BY (B)(6): A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 C-RING BECAME DETACHED DURING USE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 C-RING BECAME DETACHED DURING USE. 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
    737831 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25108961

    Patients

    Seq Age Sex Outcome Treatment
    1