BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 14987660 · Received July 12, 2022

    Report

    Report Number
    2210968-2022-05373
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    January 1, 2021
    Report Date
    July 12, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: BARIATRIC SURGICAL PRACTICE AND PATIENT CARE, VOLUME 16, NUMBER 2, 2021, DOI: 10.1089/BARI.2020.0068.

    Description of Event or Problem · 0

    TITLE: THE SURGICAL TECHNIQUE OF STAPLELESS LAPAROSCOPIC ONE-ANASTOMOSIS GASTRIC BYPASS WITH AN UNCUT POUCH CREATION: A RANDOMIZED CLINICAL TRIAL. THE PURPOSE OF THIS STUDY WAS TO EVALUATE A STAPLELESS AND STAPLE USE SURGICAL TECHNIQUE FOR GASTRIC BYPASS. FROM DECEMBER 2018 TO JUNE 2019, 40 MORBIDLY OBESE PATIENTS UNDERGOING GASTRIC BYPASS WERE INCLUDED IN THIS STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO 2 GROUPS WITH 20 PATIENTS WHO HAD STAPLELESS ONE-ANASTOMOSIS GASTRIC BYPASS (GROUP 1) AND 20 PATIENTS WHO UNDERWENT ONE-ANASTOMOSIS GASTRIC BYPASS WITH STAPLER USE (GROUP 2). IN GROUP 1, THERE WERE 18 FEMALES AND 2 MALES WITH A MEAN AGE OF 38.6+/-6.89 YEARS. IN GROUP 2, THERE WERE 15 FEMALES AND 5 MALES WITH A MEAN AGE OF 48.7 +/-8.54 YEARS. DURING THE BYPASS PROCEDURE, THE LIGATURE, CREATED WITH VICRYL USP 2-0 (ETHICON), WAS INTRODUCED THROUGH THE RETROGASTRIC CHANNEL, AND PULLED INTO THE RETROGASTRIC CANAL. FOR THE CREATION OF THE GASTRIC POUCH, A GASTRO-GASTRIC SUTURE WAS USED TO CLOSE THE LUMEN OF THE STOMACH BELOW THE ISTHMUS, USING NONABSORBABLE ETHIBOND 2-0 SUTURES (ETHICON). THE SIDE OF THE JEJUNAL LOOP WAS ANASTOMOSED TO THE GASTRIC POUCH USING AN ¿¿END-TO-SIDE¿¿ TECHNIQUE. A TWO-LAYERED HAND-SEWN GASTROJEJUNOSTOMY WITH A 2 CM STOMA WAS CREATED USING VICRYL USP 2-0 (ETHICON) ABSORBABLE SUTURES. THE REPORTED COMPLICATIONS INCLUDE ABDOMINAL PAIN (N=1), NAUSEA AND EMESIS (N=1), BILE REFLUX WITH GASTRITIS (N=1). IN CONCLUSION, BOTH GASTRIC BYPASS PROCEDURES SIGNIFICANTLY REDUCED WEIGHT, HOWEVER, THE STAPLELESS METHOD IS 62.78 PERCENT CHEAPER. THE SAFETY AND DURATION OF EFFICACY CAN BE DISCUSSED AFTER LONGER FOLLOW-UP STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652644 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention