BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 20514932 · Received October 23, 2024

    Report

    Report Number
    3005075853-2024-07985
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    April 13, 2023
    Report Date
    October 23, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/23/2024 B3: PUBLICATION YEAR OF 2024 . 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/BATCH 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. 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.

    Description of Event or Problem · 0

    TITLE: MUCOSAL INJURY DURING LAPAROSCOPIC HELLER CARDIOMYOTOMY: RISK FACTORS AND IMPACT ON SURGICAL OUTCOMES AUTHORS: EL-SAYED ABOU EI-MAGD1 ¿ AHMED ELGEIDIE 1 ¿ AMR ABBAS 1 ¿ YOUSSIF ELMAHDY 1 ¿ IBRAHEM LOTFY ABULAZM2 CITATION: SURGERY TODAY (2023) 53:1225-1235. HTTPS:/ /DOI.ORG/ 10.1007 / S00595-023-02680-2. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE RISK FACTORS AND OUTCOMES OF MUCOSAL PERFORATION (MP) DURING LAPAROSCOPIC HELLER MYOTOMY (LHM) IN PATIENTS WITH ACHALASIA. BETWEEN JANUARY, 2002 AND DECEMBER, 2020, A TOTAL OF 412 PATIENTS DIAGNOSED WITH ESOPHAGEAL ACHALASIA WHO UNDERWENT A LAPAROSCOPIC HELLER MYOTOMY PROCEDURE WERE INCLUDED IN THE STUDY. THE MYOTOMY WAS DONE VIA DIATHERMY, WITH A HARMONIC SCALPEL (ETHICON ENDO-SURGERY, USA) OR WITH A LIGASURE (COVIDIEN, USA). THEN, THE UPPER SHORT GASTRIC VESSELS WERE DIVIDED TO PREPARE THE FUNDUS FOR DOR FUNDOPLICATION, WHICH WAS DONE USING 2/0 SILK SUTURES. WHEN MUCOSAL INJURY WAS DIAGNOSED, IT WAS REPAIRED USING INTERRUPTED 4/0 VICRYL SUTURES. GROUP A COMPRISED THE 52 PATIENTS (24 MALE AND 28 FEMALE; MEAN AGE WAS 49.06 ± 15.78 YEARS) WITH MUCOSAL PERFORATION AND GROUP B COMPRISED THE REMAINING 360 PATIENTS (160 MALE AND 200 FEMALE; MEAN AGE WAS 41. 11 ± 12.96 YEARS) WHO DID NOT SUFFER THIS COMPLICATION. THE MEDIAN DURATION OF FOLLOW-UP WAS 57 MONTHS FOR GROUP A AND 49 MONTHS FOR GROUP B. REPORTED COMPLICATIONS INCLUDE MUCOSAL PERFORATION (N=36), POSTOPERATIVE HEARTBURN (N=?), RESIDUAL DYSPHAGIA (N=?), REFLUX ESOPHAGITIS (N=?), AND TREATMENT FAILURE (N=?). IN CONCLUSION, MANY RISK FACTORS FOR MP HAVE BEEN IDENTIFIED. CORRECTABLE PARAMETERS LIKE LOW SERUM ALBUMIN SHOULD BE RESOLVED PRIOR TO SURGERY, WHILE UNCORRECTABLE PARAMETERS LIKE OLD AGE AND A SIGMOID-SHAPED ESOPHAGUS SHOULD BE MANAGED BY EXPERIENCED SURGEONS IN HIGH-VOLUME CENTERS. IMPLEMENTING THESE RECOMMENDATIONS WILL HELP DECREASE THE INCIDENCE AND CONSEQUENCES OF THIS SERIOUS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317066 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention