BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGASOFT UNIVERSAL

    MDR report key: 16112399 · Received January 6, 2023

    Report

    Report Number
    1721194-2023-00003
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 28, 2023
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559103906
    PMA / PMN Number
    K133726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. SERIAL NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THE DEVICE SELF-ACTIVATED WITHOUT ANY ACTIVATION BY THE USER? COULD YOU PLEASE CONFIRM THE PRODUCT CODE OF THE BIPOLAR FORCEPS? COULD YOU PLEASE CONFIRM WHAT IS THE SEVERITY OF THE BURN? (PLEASE SEE DEGREES OF BURNS BELOW AND CHOOSE ONE). O FIRST DEGREE BURNS ARE MINOR BURNS ON THE FIRST LAYER OF SKIN. THE SKIN LOOKS DRY, REDNESS, AND MAY BE SWELLING; NO PENETRATION OR BLISTERS. O SECOND DEGREE BURN LOOKS WET OR MOIST. THE BURN SITE APPEARS RED, BLISTERED, AND MAY BE SWOLLEN AND PAINFUL. O THIRD DEGREE BURN THE BURN SITE LOOKS DEEP, WHITENING OR BLACKENED AND CHARRED. WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES) BESIDES THE BURN, DID THE PATIENT EXPERIENCE ANY ADVERSE CONSEQUENCE DUE TO THE ISSUE? ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN OR INJURY? WHAT IS THE CURRENT STATUS OF THE AFFECTED (PATIENT OR USER)? ANSWER = THE BIPOLAR FORCEPS THAT WERE OPEN FOR THE CASE WERE STRYKER BRAND WITH THE FOLLOWING PRODUCT CODES AND LOT NUMBERS; 6730-160-010 1.0MM, TIP, LOT#: 52982. 6730-160-004 0.4MM, TIP, LOT#: 51543. 6730-160-007 0.7MM, TIP, SN#: (B)(4), LOT#: 213644. 6715-100-007 0.7MM, TIP, LOT#: 246741. IT IS UNCLEAR TO ME EXACTLY WHAT HAPPENED, BUT I WAS TOLD THAT THEY HAD AN ISSUE WITH THE FORCEPS NOT ACTIVATING AND SO THEY OPENED A NEW CORD AND NEW FORCEPS AND WHILE SETTING THEM UP A FIRE STARTED NEAR THE PATIENT'S FACE (PATIENT HAD A NASAL CANNULA IN). I WAS TOLD THE PATIENT WAS SENT TO ICU AS A PRECAUTION AND DISCHARGED SOON AFTER BUT NOT GIVEN MORE INFORMATION ABOUT THE EXTENT OF INJURIES. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND CERTED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE EQUIPMENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED:ARE THERE ANY PHOTOS OF THE BURN THAT YOU COULD SHARE WITH US IN REGARDS TO THE BURN? IF YES, PLEASE SEND TO (B)(6).. WHEN WERE THE BURNS FIRST NOTICED? WHAT IS THE SEVERITY OF THE BURN? (PLEASE SEE DEGREES OF BURNS BELOW AND CHOOSE ONE) FIRST DEGREE BURNS ARE MINOR BURNS ON THE FIRST LAYER OF SKIN. THE SKIN LOOKS DRY, REDNESS, AND MAY BE SWELLING; NO PENETRATION OR BLISTERS. SECOND DEGREE BURN LOOKS WET OR MOIST. THE BURN SITE APPEARS RED, BLISTERED, AND MAY BE SWOLLEN AND PAINFUL. THIRD DEGREE BURN THE BURN SITE LOOKS DEEP, WHITENING OR BLACKENED AND CHARRED WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES) BESIDES THE BURN, DID THE PATIENT EXPERIENCE ANY ADVERSE CONSEQUENCE DUE TO THE ISSUE? ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN OR INJURY? WHAT IS THE CURRENT STATUS OF THE PATIENT? HOW WAS THE PATIENT POSITIONED? DOES THE SURGEON BELIEVE THERE IS THERE AN ALLEGED DEFICIENCY TO THE MEGEN1 THAT LED TO PATIENT BURN AND IF SO WHY? WERE THE STRYKER FORCEPS ACTIVATED IN AN OXYGEN ENRICHED ENVIRONMENT? ANSWER - I PROVIDED AS MUCH INFORMATION AS THE ACCOUNT WAS ABLE TO SHARE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/2/2023. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE 0845 PAD WAS RETURNED WITH DISCOLORATION ON THE TOP SURFACE. THE PAD WAS CONNECTED TO THE GENERATOR AND PERFORMED AS EXPECTED. IN ADDITION, IT WAS FUNCTIONALLY TESTED WITH A MULTIMETER AND NO ANOMALIES WERE NOTED. THERE WERE NO ISSUES RELATED TO THE REPORTED EVENT. THE MOST LIKELY CAUSE OF THIS DAMAGE IS RELATED TO THE CLEANING PROCESS. PLEASE BE AWARE THAT MOST CLEANING AGENTS LEAVE RESIDUAL ACTIVE INGREDIENT CHEMICALS ON THE SURFACE OF THE DEVICES THAT ARE CLEANED. FOR THIS REASON MEGADYNE RECOMMENDS RINSING THE CLEANER/DISINFECTANT OFF OF THE SURFACE OF THE PAD. AS PART OF ETHICON ENDO SURGERY QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LIP LESION REMOVAL PROCEDURE THAT THE BIPOLAR FORCEPS WERE INADVERTENTLY ACTIVATED IN OPEN AIR USING THE FOOT PEDAL AND NEAR A NASAL CANNULA, WHICH CAUSED A FIRE. CUSTOMER STATES BIOMED CHECKED EQUIPMENT AND IT WAS OPERATING NORMALLY. PATIENT SUSTAINED BURNS TO FACE AND HAD TO STAY OVERNIGHT IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392042 MEGASOFT UNIVERSAL MEGA SOFT UNIVERSAL GEI MEGADYNE MEDICAL PRODUCTS, INC. 0845 10614559103906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H