BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7393284 · Received April 3, 2018

    Report

    Report Number
    2210968-2018-71842
    Event Type
    Injury
    Date Received
    April 3, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT 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 THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: OBES SURG. 2018; 28: 218 225. DOI: 10.1007/S11695-017-2835-Y.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A RANDOMIZED COMPARISON BETWEEN STAPLE-LINE OVERSEWING VERSUS NO REINFORCEMENT DURING LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY AUTHORS: OSAMA TAHA, MAHMOUD ABDELAAL, MOHAMED TALAAT, MOHAMED ABOZEID CITATION: OBES SURG. 2018; 28: 218 225. DOI: 10.1007/S11695-017-2835-Y. THE AIM OF THIS SINGLE-CENTER RANDOMIZED STUDY WAS TO EVALUATE THE COMPLICATION RATES OF THE GASTRIC STAPLING ALONE VERSUS STAPLING WITH OVERSEWING INVAGINATION OF THE STAPLE LINE IN LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY (LSG). A TOTAL OF 400 PATIENTS (24 TO 43 YEARS OLD) WERE INCLUDED IN THE STUDY. OF WHICH, 200 PATIENTS UNDERWENT LSG WITHOUT REINFORCEMENT OF THE STAPLE-LINE (GROUP 1) AND 200 PATIENTS UNDERWENT REINFORCED LSG BY A SEROSEROSAL OVERSEWING ALONG THE ENTIRE STAPLE-LINE (GROUP 2). THE SLEEVE IS CREATED IN A STANDARD FASHION THROUGH THE 5-PORT TECHNIQUE AND USAGE OF FR 26 BOUGIES FOR CALIBRATIONS. THE GREATER OMENTUM WAS DISSECTED BY USING THE HARMONIC SCALPEL FROM 2 TO 4 CM PROXIMAL TO THE PYLORUS TO THE ANGLE OF HIS. IN GROUP 2, THE REMNANT GASTRIC TUBE WAS OVERSEWN BY INVAGINATION OF THE STAPLE LINE USING VICRYL 3-0 CONTINUOUS SEROSEROSAL SUTURES. IN GROUP 1, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1), PROLONGED VOMITING (N-9) IN WHICH A PROGRESSIVE ENDOSCOPIC GASTRIC DILATATION WAS DONE IN 1 PATIENT, STAPLE-LINE LEAKAGE (N-1), AND STAPLE-LINE BLEEDING (N-18). IN GROUP 2, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-3), PROLONGED VOMITING (N-18) IN WHICH A SECONDARY SURGICAL INTERVENTION TO EVACUATE A LESSER CURVATURE HEMATOMA LAPAROSCOPICALLY WAS DONE IN 1 PATIENT, AND STAPLE-LINE BLEEDING (N-4). IT WAS CONCLUDED THAT OVERSEWING OF THE STAPLE LINE DURING LSG IS A NON-EXPANSIVE AND EASY METHOD TO DECREASE THE INCIDENCE AND SEVERITY OF THE POSTOPERATIVE BLEEDING. HOWEVER, IT IS TIME CONSUMING AND SHOULD BE PERFORMED BY EXPERIENCED SURGEONS TO AVOID THE COMPLICATIONS WHICH MAY OCCUR SECONDARY TO THE SEROSEROTOMY SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237574 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention