BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8387757 · Received March 4, 2019

    Report

    Report Number
    2210968-2019-79237
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    February 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. CITATION: SURG ENDOSC (2003) 17: 378¿380; DOI: 10.1007/S00464-002-8843-5. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: RESULT OF 310 CONSECUTIVE PATIENTS UNDERGOING LAPAROSCOPIC NISSEN FUNDOPLICATION AS HOSPITAL OUTPATIENTS OR AT A FREE-STANDING SURGERY CENTER". AUTHOR/S: S. RAY. CITATION: SURG ENDOSC (2003) 17: 378¿380; DOI: 10.1007/S00464-002-8843-5. THIS STUDY AIMED TO PRESENT THE RESULT OF THE PATIENTS UNDERGOING LAPAROSCOPIC NISSEN FUNDOPLICATION AS AN OUTPATIENT PROCEDURE. OVER A 4-YEAR PERIOD, 310 PATIENTS (N=148 MALE AND N=162 FEMALE; AVERAGE AGE OF 53 YEARS [20-83 YEARS]; AVERAGE WEIGHT OF 185 POUNDS [RANGED 85-324 POUNDS]) WITH GASTROESOPHAGEAL REFLUX DISEASE UNDERWENT LAPAROSCOPIC NISSEN FUNDOPLICATION. IN THE PROCEDURE, SHORT GASTRICS AND GASTROPHRENIC LIGAMENTS WERE DIVIDED BY A 5-MM HARMONIC SCALPEL THUS FACILITATING FULL FUNDIC MOBILITY. CRURAL STITCHES WERE PLACED TO CLOSE THE HIATAL DEFECT WITH THE 0-ETHIBON INTERRUPTED STITCH USING ESS ETHICON SUTURE SYSTEM, ETHICON ENDO-SURGERY, INC., (B)(6), USA) IN ALL CASES. COMPLICATIONS INCLUDED GASTRIC PERFORATION (N=2) TREATED BY LAPAROSCOPIC CLOSURE OF THE PERFORATION AND UNDERWENT A FULL 360° WRAP; SIGNIFICANT BLEED FROM THE SHORT GASTRIC ARTERY (N=1); INABILITY TO KEEP LIQUIDS DOWN (N=10) WHICH UNDERWENT INTRAVENOUS HYDRATION AND AN ESOPHAGOGASTRODUODENOSCOPY WITH BALLOON DILATION OF THE ESOPHAGOGASTRIC (EG) JUNCTION, RESULTING IN RESOLUTION OF THEIR SYMPTOMS AND ADDITIONALLY IN FOUR PATIENTS POSTOPERATIVE DILATIONS OF THE EG JUNCTION WITHIN 6 MONTHS AFTER THE PROCEDURE; DYSPHAGIA (N=1) TREATED BY REMOVAL OF CRURAL STITCH WITH RESOLUTION OF SYMPTOMS; GASTRIC BLOATING (N=3) TREATED WITH REGLAN 10MG THREE TIMES DAILY WITH SIGNIFICANT SYMPTOMATIC IMPROVEMENT; RECURRENT REFLUX/HEARTBURN (N=11) TREATED WITH REPEAT LAPAROSCOPIC NISSEN FUNDOPLICATION WITH RESOLUTION OF SYMPTOMS (N=2) AND THE REMAINING NINE CHOSE TO REMAIN ON MEDICATION. ADEQUATE MOBILIZATION OF THE FUNDUS BY DIVIDING THE SHORT GASTRICS AND THE GASTROPHRENIC LIGAMENT IS IMPORTANT IN ACHIEVING A LOOSE WRAP. ATTENTION MUST BE GIVEN TO AVOIDING ANY INJURY TO THE VAGUS NERVE, AND CRURAL CLOSURE SHOULD BE PERFORMED IN ALL PATIENTS IN THE SERIES, FAILURE OF THE PROCEDURE HAS BEEN RELATED TO WEAK CRURAL MUSCLES, LARGE SIZE OF THE HIATAL HERNIA, SLIPPED NISSEN, OR SUTURE BREAK. SEVERE BUCKING DURING EXTUBATION, VOMITING, AND SNEEZING DURING THE IMMEDIATE POSTOPERATIVE PERIOD MAY HAVE CONTRIBUTED TO TWO FAILURES IN THE SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179863 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5-MM HARMONIC SCALPEL