BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12442725 · Received September 8, 2021

    Report

    Report Number
    2210968-2021-08156
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 5, 2019
    Report Date
    August 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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. PATIENT DEMOGRAPHICS? 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: SURGICAL ENDOSCOPY (2020); 34:2495¿2502. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07055-8.

    Description of Event or Problem · 1

    TITLE: ROBOT-ASSISTED HIATAL HERNIA REPAIR DEMONSTRATES FAVORABLE SHORT-TERM OUTCOMES COMPARED TO LAPAROSCOPIC HIATAL HERNIA REPAIR. THE AIM OF THIS SINGLE-CENTER, RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATABASE WAS TO DETERMINE SHORT-TERM SURGICAL OUTCOMES WITH A ROBOT-ASSISTED HIATAL HERNIA REPAIR AND CONVENTIONAL LAPAROSCOPIC HIATAL HERNIA REPAIR. BETWEEN 2012 TO 2017, A TOTAL OF 293 PATIENTS (27.3% MALE; MEAN AGE = 62 YEARS; MEDIAN BMI = 29.5) WHO UNDERWENT ELECTIVE HIATAL HERNIA REPAIR USING EITHER LAPAROSCOPY OR THE DA VINCI XI ROBOT, WERE INCLUDED IN THE STUDY. THE LAPAROSCOPIC PROCEDURE WAS PERFORMED USING A COMPETITOR DEVICE IN 151 PATIENTS. IN 142 PATIENTS, THE ROBOTIC TECHNIQUE WAS PERFORMED USING 2-0 ETHIBOND SUTURE (ETHICON). IN 52/142 PATIENTS, LINX (ETHICON) WAS USED. REPORTED COMPLICATIONS INCLUDED MAJOR COMPLICATION (N=1) REQUIRING SURGICAL INTERVENTION; ANY OTHER GI EVENT (N=2); UNKNOWN EVENTS (N=7) THAT REQUIRED POSTOPERATIVE PRBC TRANSFUSION (N=2), UNANTICIPATED SURGICAL APPROACH CONVERSION (N=1), INITIAL VISIT TO ICU (N=2), UNEXPECTED ADMISSION TO ICU (N=1), AND REQUIRING OR WITH GENERAL ANAESTHESIA (N=1); OTHER INFECTION (N=2) REQUIRING IV ANTIBIOTICS; AND 30-DAY READMISSION RATE (N=5). IN CONCLUSION, THE USE OF THE DA VINCI XI ROBOT IN OUR INSTITUTION WAS ASSOCIATED WITH IMPROVED OUTCOMES COMPARED TO LAPAROSCOPIC HIATAL HERNIA REPAIR DESPITE A HIGHER INCIDENCE OF RE-OPERATIVE CASES IN THE ROBOTIC GROUP. THUS, SHORT-TERM OUTCOMES OF DA VINCI XI ROBOT-ASSISTED HIATAL HERNIA REPAIR ARE NOT INFERIOR TO LAPAROSCOPIC HIATAL HERNIA REPAIR. FURTHER STUDIES ARE NEEDED TO DETERMINE IF DA VINCI XI ROBOT PROVIDES SUPERIOR SHORT-TERM AND LONG-TERM OUTCOME IN TREATMENT OF SYMPTOMATIC HIATAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340514 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention