BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE SMOKE DISSECTOR STD

    MDR report key: 21528734 · Received March 5, 2025

    Report

    Report Number
    1721194-2025-00026
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 19, 2025
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559105955
    PMA / PMN Number
    K982130
    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). DATE SENT 3/5/2025. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6. HEALTH EFFECT - CLINICAL CODE PARTIAL THICKNESS (SECOND DEGREE) BURN (E170405). H6. MEDICAL DEVICE PROBLEM CODE MEDICATION REQUIRED (F2303). H6. MEDICAL DEVICE PROBLEM CODE DIFFICULT OR DELAYED ACTIVATION (A150102). B3: ONLY EVENT YEAR KNOWN: 2025. 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. NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE SEVERITY OF THE BURN? (PLEASE SEE DEGREES OF BURNS BELOW AND CHOOSE ONE). SECOND DEGREE. WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES). THEY ALL WASHED THEIR FINGERS (WITH LAB PERSONNEL) WITH SOAP AND PUT NEOSPORIN AND A BANDAID ON THE AREA. ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN OR INJURY? NO ANTICIPATED LONG TERM EFFECTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DO YOU HAVE A PHOTO OF THE BURNS THAT YOU COULD PLEASE SEND US? [email protected]. ARE ANY OF THE PRODUCTS USED RETURNING FOR ANALYSIS? WOULD THE SURGEONS LIKE A CALL WITH ETHICON TO DISCUSS THIS ISSUE? IF YES, PLEASE PROVIDE 3 DATES AND TIMES (EST) THAT MIGHT WORK. WHAT INSTRUMENT WERE THE SURGEONS IN CONTACT WITH THE TIME THE BURNS WERE NOTICED? HOW FAR WAS THE BOVIE TIP FROM THE SURGEON¿S GLOVE? WERE THERE ANY OTHER METAL INSTRUMENTS IN TOUCH WITH THE SURGEONS DURING THE BURN? WHAT PROCEDURE WAS BEING COMPLETE? WHAT IS THE SURGEONS EXPERIENCE WITH THE INSTRUMENTS? DOES THE SURGEON BELIEVE THE ISSUE WAS RELATED TO AN ALLEGED DEFICIENCY OF THE DEVICE (S) OR WERE THERE OTHER CONTRIBUTING FACTORS? PLEASE EXPLAIN. 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). DATE SENT: 3/19/2025. CORRECTED DATA: B1, B2, H1. THIS FILE WAS REVIEWED BY A CROSS FUNCTIONAL TEAM DURING THE WEEKLY AE REVIEW MEETING AS A RESULT, UPON REVIEW OF THE FILE WITH MEDICAL SAFETY OFFICER THE SURGEON DID RECEIVE A SECOND-DEGREE BURN. HOWEVER, THERE WAS NO EVIDENCE THAT ANY MEDICAL/SURGICAL INTERVENTION WAS NEEDED TO TREAT THE BURN, NOR CONSEQUENCE FOR THE BURN INJURY REPORTED. THE ONLY TREATMENT THAT WAS GIVEN WAS ¿THEY ALL WASHED THEIR FINGERS (WITH LAB PERSONNEL) WITH SOAP AND PUT NEOSPORIN AND A BAND AID ON THE AREA¿, THEREFORE THIS DOES NOT MEET THE SERIOUS INJURY REPORTING REQUIREMENT UNDER 21 CFR PART 803. THE FILE WILL REMAIN REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/14/2025. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DO YOU HAVE A PHOTO OF THE BURNS THAT YOU COULD PLEASE SEND US? [email protected]. ARE ANY OF THE PRODUCTS USED RETURNING FOR ANALYSIS? WOULD THE SURGEONS LIKE A CALL WITH ETHICON TO DISCUSS THIS ISSUE? IF YES, PLEASE PROVIDE 3 DATES AND TIMES (EST) THAT MIGHT WORK. WHAT INSTRUMENT WERE THE SURGEONS IN CONTACT WITH THE TIME THE BURNS WERE NOTICED? HOW FAR WAS THE BOVIE TIP FROM THE SURGEON¿S GLOVE? WERE THERE ANY OTHER METAL INSTRUMENTS IN TOUCH WITH THE SURGEONS DURING THE BURN? WHAT PROCEDURE WAS BEING COMPLETE? WHAT IS THE SURGEONS EXPERIENCE WITH THE INSTRUMENTS? DOES THE SURGEON BELIEVE THE ISSUE WAS RELATED TO AN ALLEGED DEFICIENCY OF THE DEVICE (S) OR WERE THERE OTHER CONTRIBUTING FACTORS? PLEASE EXPLAIN. WE DO NOT HAVE A PHOTO OF THE BURNS. THERE ARE NO PRODUCT RETURNS AS THIS WAS A CADAVER LAB ENVIRONMENT. THE SURGEONS DO NOT REQUEST CALLS. SOME WERE HOLDING METAL DISSECTORS AND OTHERS WERE USING THE BOVI RIGHT ON THEIR GLOVE. I DID NOT SEE IT HAPPEN, SO I DO NOT KNOW FOR SURE WHAT HAPPENED. THE SURGEONS ALSO DO NOT KNOW WHAT HAPPENED AND ARE NOT SURE WHY THEY WERE BURNED. WE DISCUSSED POTENTIALLY THEY WERE COMPLETING THE CIRCUIT TOUCHING THE PATIENT AND OPERATING THE BOVI ON THEIR GLOVE, WE ALSO DISCUSSED THAT THERE COULD HAVE BEEN SOME INTERACTION WITH THE METAL INSTRUMENTS BEING USED CLOSE TO THEIR HAND WITH ARCING OR DIRECT COUPLING. AGAIN, THEY ARE NOT SURE BUT THEY HAVE EXPERIENCE WITH THESE PRODUCTS AND PROCEDURES. THE PROCEDURES BEING COMPLETED WERE FIBULA FLAPS FOR H&N RECONSTRUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479982 TELESCOPE SMOKE DISSECTOR STD RETURN ELECTRODE CABLE, DUAL PLATE GEI MEGADYNE MEDICAL PRODUCTS, INC. 10614559105955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention