BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PATIENT RETURN ELECTRODES - ACCESSORY

    MDR report key: 12049107 · Received June 23, 2021

    Report

    Report Number
    1721194-2021-00052
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    August 8, 2020
    Report Date
    June 14, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K133726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/28/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN WITH THE BLEEDING AND THE INFECTION AND THE PATIENT HAD TO RETURN TO THE HOSPITAL, DID THE PATIENT(S) HAVE TO BE RE-ADMITTED DUE TO THESE ISSUES? ANSWER = I DO NOT BELIEVE YOUR DEVICE CAUSED THE COMPLICATIONS REPORTED IN THIS STUDY. THESE COMPLICATIONS ARE INHERENT TO THE PROCEDURE REGARDLESS OF THE DEVICE USED. THE STUDY DID NOT DEMONSTRATE A SIGNIFICANT DIFFERENCE IN COMPLICATIONS BETWEEN THE CAUTERY AND COBLATOR. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4); INFECTIONS: THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN WITH THE BLEEDING AND THE INFECTION AND THE PATIENT HAD TO RETURN TO THE HOSPITAL, DID THE PATIENT(S) HAVE TO BE RE-ADMITTED DUE TO THESE ISSUES?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RADIOFREQUENCY ABLATION VS ELECTROCAUTERY BLINDED RANDOMIZED TRIAL: IMPACT ON CLINICALLY MEANINGFUL OUTCOMES AUTHORS: AARON J. PRUSSIN MD, ERIC BABAJANIAN MD, MARC ERROR MD, J. FREDRIK GRIMMER MD, JESSICA KU MPH, BRYAN MCRAE MD, JEREMY MEIER MD, HEATHER THIESSET PHD MPH, AND JONATHAN R. SKIRKO MD MHPA MPH CITATION: OTOLARYNGOLOGY¿HEAD AND NECK SURGERY 2021, VOL. 164(6) 1186¿1192; DOI: 10.1177/0194599820964737. THE OBJECTIVE OF THIS RANDOMIZED DOUBLE-BLINDED STUDY IS TO ANALYZE PATIENTS¿ RETURN TO NORMAL ACTIVITY, PAIN SCORES, NARCOTIC USE, AND ADVERSE EVENTS AFTER UNDERGOING TONSILLECTOMY OR ADENOTONSILLECTOMY WITH MONOPOLAR ELECTROCAUTERY OR RADIOFREQUENCY ABLATION. BETWEEN (B)(6) 2018 AND (B)(6) 2019, 236 PATIENTS WITH SURGICAL INDICATION OF RECURRENT TONSILLITIS OR AIRWAY OBSTRUCTION/SLEEP-DISORDERED BREATHING WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMLY ASSIGNED TO MONOPOLAR ELECTROCAUTERY PROCEDURE USING MEGADYNE MONOPOLAR ELECTROCAUTERY (ETHICON) OR RADIOFREQUENCY ABLATION PROCEDURE USING A COMPETITOR¿S DEVICE. A TOTAL OF 230 PATIENTS COMPLETED THE STUDY, WITH 112 ASSIGNED TO THE RADIOFREQUENCY ABLATION GROUP AND 118 ASSIGNED TO THE MONOPOLAR ELECTROCAUTERY GROUP. THERE WERE 103 PATIENTS WITH AGES FROM 3-6 YEARS OLD CONSISTING OF 48 MALES AND 55 FEMALES. THERE WERE 53 PATIENTS WITH AGES FROM 7-11 YEARS OLD CONSISTING OF 25 MALES AND 28 FEMALES. THERE WERE 30 PATIENTS WITH AGES FROM 12-17 YEARS OLD CONSISTING OF 10 MALES AND 20 FEMALES. THERE WERE 40 PATIENTS WITH AGES FROM 18 YEARS OLD AND ABOVE CONSISTING OF 13 MALES AND 31 FEMALES. BOTH GROUPS UNDERWENT SUBCAPSULAR TONSILLECTOMY. DURING THE PROCEDURE, ELECTROCAUTERY SETTINGS WERE 6 TO 15 W FOR TONSILLECTOMY AND 6 TO 20 W FOR HEMOSTASIS IN THE TONSILLAR FOSSA. RADIOFREQUENCY ABLATION SETTINGS WERE 7 FOR TONSILLECTOMY AND 3 FOR HEMOSTASIS. ALL PATIENTS RECEIVED INTRAOPERATIVE DEXAMETHASONE (0.2 MG/KG, WITH A MAXIMUM DOSE OF 10 MG). ALL PATIENTS HAD ORAL ANALGESIA STARTED IN THE POSTANESTHESIA CARE UNIT AND CONTINUED AT HOME. SURVEY QUESTIONS ANSWERED VIA TEXT OR EMAIL WERE COLLECTED DAILY UNTIL POSTOPERATIVE DAY 15. THE PRIMARY OUTCOME WAS THE PATIENT¿S RETURN TO NORMAL ACTIVITY. SECONDARY OUTCOMES INCLUDED DAILY PAIN SCORE, TOTAL AMOUNT OF POSTOPERATIVE NARCOTIC USE, AND ADVERSE EVENTS. COMPLICATIONS INCLUDED POSTOPERATIVE PAIN FROM DAYS 1-15 WITH SLIGHTLY WORSE PAIN AT POSTOPERATIVE DAY 1 (N=?), BLEEDING (N=2), AND INFECTION (N=1). IN CONCLUSION, OUR STUDY DEMONSTRATES NO SIGNIFICANT DIFFERENCE IN RETURN TO NORMAL ACTIVITY BETWEEN THE RADIOFREQUENCY ABLATION AND MONOPOLAR ELECTROCAUTERY GROUPS. THERE IS A STATISTICALLY SIGNIFICANT DIFFERENCE IN POD 1 PAIN WHEN DAILY PAIN SCORES ARE EVALUATED INDIVIDUALLY, WITH THE MONOPOLAR ELECTROCAUTERY GROUP HAVING SLIGHTLY WORSE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945437 UNK_PATIENT RETURN ELECTRODES - ACCESSORY MEGA SOFT REPAIR KIT GEI MEGADYNE MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention