BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 11697018 · Received April 20, 2021

    Report

    Report Number
    3005075853-2021-02137
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    December 5, 2019
    Report Date
    March 25, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019. BATCH # UNK. 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. WHAT WERE THE SPECIFIC NUMBER OF PATIENTS WHO HAD POSTOPERATIVE PAIN IN GROUP A AND GROUP B AT 1 DAY AFTER SURGERY, PRIOR TO DISCHARGE, AT 1 WEEK, 2 WEEKS, 1 MONTH, AND 6 MONTH AFTER SURGERY? DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: COMPARISON OF MESH FIXATION AND NONFIXATION IN LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR OF INGUINAL HERNIA AUTHORS: BEHROOZ KALIDAREI, MOHSEN MAHMOODIEH, ZAKARIA SHARBU CITATION: FORMOSAN JOURNAL OF SURGERY. 2019; 52 (6): 212-220. DOI: 10.4103/FJS.FJS_15_19. THE AIM OF THIS PRESENT RANDOMIZED CLINICAL TRIAL WAS TO EVALUATE THE INCIDENCE RATE OF COMPLICATIONS SUCH AS URINARY RETENTION, SEROMA, WOUND INFECTION, AND RECURRENCE OF HERNIA, AFTER APPLYING TWO METHODS OF FIXED AND NONFIXED TAPP IN AN IRANIAN POPULATION DURING 6 MONTHS AFTER OPERATION. IN ADDITION, THIS STUDY EVALUATED THE PATIENTS¿ PAIN LEVEL AND MADE ATTEMPTS TO REPORT MORE ACCURATE RESULTS BY DISTINGUISHING THE DIRECT AND INDIRECT TYPES OF HERNIA. BETWEEN APRIL 2017 TO MARCH 2018, A TOTAL OF 80 PATIENTS WITH INGUINAL HERNIA UNDERWENT TAPP LAPAROSCOPY WITH MESH FIXATION (N = 41; 31 MALE AND 10 FEMALE; MEAN AGE = 50.51 ± 10.23 YEARS) AND NONFIXATION (N = 39; 32 MALE AND 7 FEMALE; MEAN AGE = 53.87 ± 8.37 YEARS) IN AL ZAHRA HOSPITAL. SURGERY WAS PERFORMED IN BOTH GROUPS USING A HARMONIC SCALPEL (ETHICON) AND A 10 CM × 15 CM-MESH (PROLENE MESH; ETHICON). MESH WAS FIXED USING A COMPETITOR SUTURE OR OR SPIRAL TACKS IN GROUP A AND NONFIXED IN GROUP B. CONTINUOUS ABSORBABLE SUTURES (VICRYL 3/0; ETHICON) WERE USED TO CLOSE THE PERITONEUM IN BOTH GROUPS. REPORTED COMPLICATIONS INCLUDED SEROMA (N=5); WOUND INFECTION (N=2); URINARY RETENTION (N=19); NEURALGIA (N=12); HERNIAL RECURRENCE (N=2); POSTOPERATIVE PAIN SCORE OF 3.61±2.35 AT 1 DAY AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 3.00±2.22 AT 1 DAY AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 3.34±2.26 PRIOR TO DISCHARGE (N=?); POSTOPERATIVE PAIN SCORE OF 2.03±2.18 PRIOR TO DISCHARGE (N=?); POSTOPERATIVE PAIN SCORE OF 2.76±1.62 AT 1 WEEK AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 1.74±1.50 AT 1 WEEK AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 1.41±1.29 AT 2 WEEKS AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 2.34±1.37 AT 2 WEEKS AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 1.32±1.47 AT 1 MONTH AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 1.00±0.92 AT 1 MONTH AFTER SURGERY (N=?); POSTOPERATIVE PAIN SCORE OF 0.66±1.17 AT 6 MONTHS AFTER SURGERY (N=?); AND POSTOPERATIVE PAIN SCORE OF 0.26±0.59 AT 6 MONTHS AFTER SURGERY (N=?). IN CONCLUSION, MESH NONFIXATION CAUSES LESS POSTOPERATIVE COMPLICATIONS AND PAIN IN PATIENTS UNDERGOING TAPP REPAIR; HOWEVER, IN LONG-TERM FOLLOW-UP, THE LEVEL OF CHRONIC PAIN FOLLOWING THE APPLICATION OF MESH FIXATION AND NON-FIXATION METHODS IS NOT DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592681 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention