BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8200459 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78051
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. CITATION: WORLD J SURG (2010) 34: 765¿767; DOI 10.1007/S00268-009-0365-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "A TIME-SAVING TECHNIQUE FOR SPECIMEN EXTRACTION IN SLEEVE GASTRECTOMY." AUTHOR(S): GIOVANNI CASELLA, EMANUELE SORICELLI, ALDO FANTINI, NICOLA BASSO. CITATION: WORLD J SURG (2010) 34: 765¿767; DOI 10.1007/S00268-009-0365-Z. THIS STUDY AIMED TO DESCRIBE THE TECHNIQUE FOR SPECIMEN EXTRACTION USED IN MORE THAN 250 LAPAROSCOPIC SLEEVE GASTRECTOMY PERFORMED. SINCE OCT2002, MORE THAN 250 OBESE PATIENTS UNDERWENT SLEEVE GASTRECTOMY (SG). SG WAS PERFORMED USING EITHER LINEAR STAPLER ENDO-GIA OR ECHELON ENDOPATH WITH GOLD CARTRIDGES. IN THE FIRST 90 LSG PATIENTS, SPECIMEN WAS EXTRACTED IN A RETRIEVAL BAG USING AN ENDOLOOP; IN THE FOLLOWING 160 CASES, THE GRASPED SPECIMEN WAS WITHDRAWN THROUGH 15-MM TROCAR SITE WITHOUT ANY ADDITIONAL DEVICE. CLOSURE OF TROCAR SITE WAS ACHIEVED WITH A VICRYL 1-0 CROSS STITCH, USING A BERCY NEEDLE. OVERALL, THERE WERE ONLY TWO CASES OF WOUND INFECTION USING THIS TECHNIQUE. THIS COMPLICATION DID NOT OCCUR IN THE SUBSEQUENT 130 CASES IN WHICH THE TROCAR-ACCESS SITE WAS DISINFECTED WITH POVIDONE-IODINE SOLUTION. THE GASTRIC EMPTYING BEFORE THE RESECTION, THE GENTLE TRACTION OF THE SPECIMEN WITHOUT RUPTURE, AND THE THOROUGH DISINFECTION OF THE TROCAR-ACCESS SITE SEEM TO BE KEY TO DECREASING THE INCIDENCE OF WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038003 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention