BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16897141 · Received May 9, 2023

    Report

    Report Number
    2210968-2023-03482
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    January 1, 2022
    Report Date
    May 9, 2023
    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 · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H 6. HEALTH EFFECT - IMPACT CODE: F24 ¿ INTENDED TO CAPTURE THE UNKNOWN TREATMENT FOR THE INFECTION. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION CITE: DOI: 10.1089/BARI.2021.0033. EVENT RELATED TO MW # 2210968-2023-03481, MW # 2210968-2023-03483. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: STAPLE LINE COMPLICATIONS WITHOUT REINFORCEMENT, WITH OVERSEWING AND WITH BUTTRESSING USING OXIDIZED REGENERATED CELLULOSE IN LAPAROSCOPIC SLEEVE GASTRECTOMY, RANDOMIZED COMPARATIVE STUDY. AUTHORS: OSAMA TAHA, MD, PHD, SAMIA SAIED, MD, PHD, MOHAMED SHOEIB, MD, PHD, MAHMOUD ABDELAAL, MD, PHD, MOHAMED ABOZEID, MD, PHD, AND MOHAMED TALAAT, MD. . CITATION CITE: DOI: 10.1089/BARI.2021.0033. THIS STUDY AIMS TO COMPARE THE OUTCOMES OF NO-REINFORCEMENT, STAPLE LINE OVERSEWING AND STAPLE LINE BUTTRESSING WITH ORC IN LSG. BETWEEN MARCH 2017 AND MARCH 2019, 300 PATIENTS WERE INCLUDED IN THIS RANDOMIZED STUDY, WHICH WAS CARRIED OUT IN THE BARIATRIC SURGERY . PATIENTS WERE RANDOMIZED INTO THREE GROUPS: 100 PATIENTS UNDERWENT LSG WITHOUT REINFORCEMENT, 100 PATIENTS UNDERWENT LSG WITH OVERSEWING OF THE STAPLE LINE, AND 100 PATIENTS UNDERWENT LSG WITH STAPLE LINE BUTTRESSING BY USING ORC. IN GROUP A, THE GREATER OMENTUM WAS DISSECTED BY USING THE HARMONIC SCALPEL (ETHICON ENDO- SURGERY). FOR GROUP B PATIENTS, THE OPERATIVE PROCEDURE PROCEEDED TILL COMPLETION OF THE GASTRIC SLEEVE AND THEN THE STAPLE LINE WAS REINFORCED BY CONTINUOUS OVERSEWING USING ABSORBABLE 3-0 (VICRYL). FOR PATIENTS IN GROUP C, THE OPERATIVE TECHNIQUE WAS SIMILAR TO THAT OF GROUP A PATIENTS WITH USING ORC (SURGICEL SNOW HAEMOSTAT, ETHICON, LLC). THE ABDOMINAL DRAIN WAS APPLIED AND PORT SITE WOUNDS WERE SUTURED BY USING MONOCRYL 3-0. REPORTED COMPLICATIONS INCLUDED INTA-OP: STAPLE LINE HEMATOMA (N=11), LEAKAGE (N=3), SLEEVE TWISTING (N=1), PORT SITE BLEEDING(N=1). POST-OP: PROLONGED VOMITING (N=21), POST-OP BLEEDING (N=13), WOUND INFECTION (N=8), GERD( N=12), POST-OP STAPLE LINE LEAKAGE (N=1). IN CONCLUSION OVERSEWING OF THE STAPLE LINE DURING LSG IS A NONEXPENSIVE AND EASY METHOD TO DECREASE THE INCIDENCE AND SEVERITY OF POSTOPERATIVE BLEEDING. HOWEVER, IT IS TIME CONSUMING AND ASSOCIATED WITH A HIGHER INCIDENCE OF STAPLE LINE HEMATOMA AND POSTOPERATIVE VOMITING. IT SHOULD BE PERFORMED BY EXPERIENCED SURGEONS TO AVOID COMPLICATIONS. USING ORC IS EFFECTIVE IN REDUCING STAPLE LINE BLEEDING IN LSG COMPARED WITH THE CONTROL GROUP. BOTH STAPLE LINE OVERSEWING AND ORC HAVE NO RELATION WITH OCCURRENCE OF POSTOPERATIVE GASTRIC LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841267 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention