BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7824650 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75502
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND OR VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND OR VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: JOURNAL OF LAPAROSCOPIC & ADVANCED SURGICAL TECHNIQUES. 2016; 26. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "SIMPLE PURSE STRING LAPAROSCOPIC VERSUS OPEN HERNIA REPAIR" AUTHORS: MAIRI STEVEN, MBBS, FRCS (PAED SURG), PETER CARSON, MBBS, STEPHEN BELL, MBCHB, BMEDSCI (HONS), REBECCA WARD, MBBS, MERRILL MCHONEY, MBBS, FRCS (PAED SURG), PHD CITATION: JOURNAL OF LAPARASCOPIC & ADVANCED SURGICAL TECHNIQUES. 2016; 26. DOI: 10.1089/LAP.2014.0276 THE AIM OF THIS STUDY WAS TO COMPARE SURGICAL OUTCOMES FOR A SIMPLE PURSE STRING METHOD OF LAPAROSCOPIC HERNIA (LH) REPAIR WITH A TRADITIONAL OPEN INGUINAL HERNIA (OH) REPAIR IN CHILDREN IN A SINGLE CENTER. A TOTAL OF 103 PATIENTS (23 FEMALES AND 80 MALES; AGE RANGE: 0.04¿14.7 YEARS) UNDERWENT LH REPAIR OVER THE 4-YEAR PERIOD COMPARED WITH 151 (25 FEMALES AND 126 MALES; AGE RANGE: RANGE, 0.04¿13.47 YEARS) OH PROCEDURES IN THE FIRST 2 YEARS. DURING THE LH PROCEDURE, A PURSE STRING CLOSURE AT THE INTERNAL RING (AVOIDING THE VAS AND VESSELS BY PICKING UP THE PERITONEUM ON EITHER SIDE OF THESE STRUCTURES AND BETWEEN THEM) WAS PERFORMED USING ETHIBOND 3-0 SUTURE (ETHICON). THE STANDARD OH REPAIR WAS PERFORMED VIA A GROIN CREASE INCISION THROUGH AN EXTERNAL OBLIQUE WINDOW. THE SAC WAS DISSECTED FREE OF THE VAS AND VESSELS UP TO THE INTERNAL RING, TRANSFIXED WITH VICRYL 3-0 SUTURES (ETHICON), AND THEN DIVIDED. IN THE LH GROUP, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1), RECURRENCE (N-3) WHICH WAS REPAIRED LAPAROSCOPICALLY, A (B)(6) BABY WITH METACHRONOUS HERNIA (N-1), AND PORT-SITE HERNIA (N-3). IN THE OH GROUP, REPORTED COMPLICATIONS INCLUDED RECURRENCE (N-6) WHICH REQUIRED REDO OPEN SURGERY (N-4) AND REPAIRED LAPAROSCOPICALLY (N-2) AND METACHRONOUS HERNIA (N-6). THE AUTHORS EXPERIENCE REITERATED THE USE OF NONABSORBABLE SUTURE IN LAPAROSCOPIC CASES, AS THIS COMBINATION OF LAPAROSCOPIC APPROACH AND NONABSORBABLE SUTURE GIVES THE SAME OUTCOME AS OPEN REPAIR. DUE TO THE DIFFERENT SURGICAL APPROACH OF A SIMPLE PURSE STRING CLOSURE WITHOUT HERNIOTOMY (AS IS THE CASE WITH THE OPEN PROCEDURE), THE USE OF A NONABSORBABLE SUTURE MAY ALLOW FOR CLOSURE AND SUCCESS WITHOUT THE CONCOMITANT HERNIOTOMY IN THIS SITUATION. THE AUTHORS SUGGESTED THAT LH REPAIR PERFORMED AS A SIMPLE PURSE STRING CLOSURE TECHNIQUE IS ONE THAT CAN BE EFFECTIVE AND ASSOCIATED WITH A LOW COMPLICATION RATE AND SHOULD BE CONSIDERED AT LEAST PART OF THE PEDIATRIC SURGEON¿S ARMAMENTARIUM. THE AUTHORS HAVE SHOWN THAT THE SIMPLE PURSE STRING METHOD OF LH REPAIR YIELDS SIMILAR RESULTS TO OH REPAIR IN THE SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666173 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention