BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN HEART PACK

    MDR report key: 16700898 · Received April 7, 2023

    Report

    Report Number
    1047429-2023-00003
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 26, 2023
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    OEZ
    UDI-DI
    10809160378809
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INITIALLY REVEALED THAT THE NONCONFORMANCE ROOT CAUSE WAS SUPPLIER RELATED. PHOTOS AND SAMPLES WERE RECEIVED CONFIRMING THE DEFECT. THE DETAILS WERE FORWARDED TO CONMED CORPORATION WITH A REQUEST FOR DOCUMENTATION OUTLINING THEIR FINDINGS AND ANY CORRECTIVE ACTIONS TAKEN. PER THE SUPPLIER, DURING THEIR REVIEW OF THE RETURNED PRODUCT, THEY DISCOVERED THAT THE ELECTRODE BLADE WAS NOT A CONMED DEVICE, BUT INSTEAD A MEGADYNE DEVICE. WE'VE CONFIRMED THAT ITEM: 503001, CAUTERY, BLADE 2.5" PTFE TIP (COATED EZ CLEAN ELECTRODE) (VENDOR NUMBER: (B)(4) WAS USED. THIS COMPONENT IS SUPPLIED BY J&J HEALTHCARE/ETHICON INC. (ETHI01). PER THE SUPPLIER, WHILE COMPETITOR ELECTRODES ARE COMPATIBLE WITH THE CAUTERY HOLDER, THEY NEED TO BE SIZED APPROPRIATELY. THE SUPPLIER PREFERS AND RECOMMENDS USING CONMED ELECTRODES WITH CONMED DEVICES. ADDITIONALLY, IF THE INCORRECT SIZED ELECTRODE IS USED, THE DEVICE WILL NOT FUNCTION PROPERLY. ANOTHER POTENTIAL ROOT CAUSE IS IMPROPER INSERTION, AND NOT FULLY SEATING THE ELECTRODE. UNFORTUNATELY, WITH THIS INFORMATION, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE. ACTIONS TAKEN INCLUDE A RECOMMENDATION THAT THE CUSTOMER USE CONMED ELECTRODES WITH CONMED DEVICES. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 05APR2023 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY PHYSICIAN: AT THE BEGINNING OF THE CASE AFTER MAKING THE SKIN INCISION FOR STERNOTOMY, WE NOTICED THE BOVIE WAS NOT FUNCTIONING PROPERLY - IT WAS NOT CONDUCTING WHEN ACTIVATED. WE SWITCHED THE PEN TO A DIFFERENT GENERATOR AND IT SEEMED TO WORK FOR A PERIOD OF TIME, BUT AT ONE POINT WHILE I WAS CAUTERIZING A SMALL VESSEL HELD BETWEEN MY FORCEPS, THE BOVIE CONDUCTED THROUGH MY GLOVE AND SHOCKED ME. I FOUND THIS VERY ODD AND AFTER CHANGING MY GLOVE I NOTICED A 1-2CM SUPERFICIAL LINEAR BURN ON THE PATIENTS SKIN. IT WAS IN THE STERILE FIELD BUT FAR LATERAL TO WHERE WE WERE OPERATING. IT WAS NEAR WHERE THE BOVIE CABLE WAS SECURED TO THE DRAPE. I DID NOT SEE AN OBVIOUS DEFECT IN THE CABLE BUT IT WAS AT THIS POINT WE CHANGED BOVIE PEN AND GENERATOR AGAIN AND PROCEEDED WITH THE CASE WITHOUT FURTHER INCIDENT. AT THE END OF THE CASE, THE SMALL SUPERFICIAL BURN WAS EXCISED AS AN ELLIPSE AND CLOSED PRIMARILY IN LAYERS TO MINIMIZE SCARRING. THE END RESULT IS A 2CM LINEAR INCISION ON HIS LEFT ANTERIOR CHEST WALL. AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY (REF (B)(4) OPEN HEART PACK) THAT INCLUDES THE FOLLOWING COMPONENT: CAUTERY, BUTTON HOLD EZ CLEAN, VENDOR REF: (B)(4) MANUFACTURED BY CONMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441272 OPEN HEART PACK CARDIOVASCULAR PROCEDURE KIT OEZ AVID MEDICAL, INC. VAHT026-17 1543953 10809160378809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention