BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14959554 · Received July 8, 2022

    Report

    Report Number
    2210968-2022-05284
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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. PLEASE CLARIFY WHERE THE STUDY WAS CONDUCTED: SWITZERLAND OR ITALY? DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2022). HTTPS://DOI.ORG/10.1007/S00423-022-02542-4.

    Description of Event or Problem · 0

    TITLE: THREE-POINT MESH FIXATION IN ROBOT-ASSISTED TRANSABDOMINAL PREPERITONEAL (R-TAPP) REPAIR OF 208 INGUINAL HERNIAS: PRELIMINARY RESULTS OF A SINGLE-CENTER CONSECUTIVE SERIES. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY OF OUR MESH FIXATION TECHNIQUE IN ROBOT-ASSISTED TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR (R-TAPP). BETWEEN JANUARY 2018 AND DECEMBER 2019, A TOTAL OF 208 CONSECUTIVE R-TAPP WERE PERFORMED IN 161 PATIENTS. UNILATERAL INGUINAL HERNIAS WERE 114, WHILE 47 WERE BILATERAL. TEN FEMALE PATIENTS (13 R-TAPP) AND 16 MALE PATIENTS (21 R-TAPP) WERE OPERATED FOR RECURRENT INGUINAL HERNIAS. THE MESH (COMPETITOR DEVICE) WAS FIXED BY THREE INTRACORPOREAL STITCHES USING A POLYGLACTIN 910 (VICRYL®) 3¿0 SUTURE. REPORTED COMPLICATIONS INCLUDE HEMATOMA (N=7) OF WHICH 1 REQUIRED RADIOLOGICAL DRAINAGE; SEROMA (N=3) OF WHICH 2 OF THEM REQUIRED RADIOLOGICAL DRAINAGE; CHRONIC PAIN (N=3) OF WHICH 1 REQUIRED PERCUTANEOUS ILIOINGUINAL-ILIOHYPOGASTRIC NERVE INFILTRATION; EXPRESSED DISSATISFACTION (N=1.2%); AND INGUINAL HERNIA RECURRENCE (N=1) WHICH WAS CLINICALLY DIAGNOSED AND CONFIRMED BY A CT SCAN. THE INTRAOPERATIVE DIAGNOSIS WAS PRIMITIVE BILATERAL INDIRECT HERNIA. THE R-TAPP WAS COMPLICATED BY AN INGUINAL HEMATOMA, CONSERVATIVELY TREATED, HOMOLATERAL TO THE RECURRENCE SIDE. IN CONCLUSION, THE 3-POINT MESH FIXATION TECHNIQUE IS FEASIBLE DURING ROBOT-ASSISTED TAPP REPAIR FOR INGUINAL HERNIA AND SEEMS TO BE A VIABLE ALTERNATIVE TO OTHER FIXATION METHODS. FURTHER LONG-TERM CONTROLLED INVESTIGATIONS ARE NEEDED TO UNDERSTAND IF THIS TECHNIQUE IS EFFECTIVE IN INFLUENCING RECURRENCE AND CHRONIC PAIN RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863570 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention