BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX UNKNOWN

    MDR report key: 8701322 · Received June 14, 2019

    Report

    Report Number
    2210968-2019-82772
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (STRATAFIX SUTURE) 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 PRODUCT (STRATAFIX SUTURE) USED IN THIS PROCEDURE? CITATION: OBESITY SURGERY. 2019; 29: 414¿419. DOI: HTTPS://DOI.ORG/10.1007/S11695-018-3533-0. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A STEPWISE APPROACH IN LEARNING SURGICAL RESIDENTS A ROUX-EN-Y GASTRIC BYPASS" AUTHORS: A. B. WALINGA, S. R. VAN MIL, L. U. BITER, M. DUNKELGRÜN, G. H. E. J. VIJGEN CITATION: OBESITY SURGERY. 2019; 29: 414¿419. DOI: HTTPS://DOI.ORG/10.1007/S11695-018-3533-0. THIS STUDY DESCRIBES A STEPWISE TRAINING PROGRAM TO TEACH A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB). RESULTS OF A RESIDENT ARE COMPARED TO EXPERIENCED BARIATRIC SURGEONS (EBS). BETWEEN JANUARY 2016 AND SEPTEMBER 2016, THE RESIDENT PERFORMED 29 CONSECUTIVE BARIATRIC PROCEDURES (AGE: 44 ± 9 YEARS; 25 FEMALE AND 4 MALE PATIENTS; BMI: 42.19 ± 4.22) AND 30 CONSECUTIVE PATIENTS FOR THE EBS GROUP (AGE: 40 ± 12 YEARS; 25 FEMALE AND 5 MALE PATIENTS; BMI: 39.54 ± 2.60). DURING THE SURGICAL PROCEDURE IN BOTH GROUPS, THE LRYGB IS CREATED WITH A SMALL GASTRIC POUCH OF 15 CC, WHICH IS ANASTOMOSED OVER 3 CM WITH A LINEAR STAPLER TO A 150-CM ALIMENTARY LIMB. THE GASTROJEJUNOSTOMY IS CREATED WITH A LINEAR TECHNIQUE USING AN ECHELON FLEX 60 POWERED STAPLER WITH A BLUE CARTRIDGE (ETHICON). AFTER STAPLING, THE STAPLER DEFECT IS CLOSED WITH A DOUBLE LAYER STRATAFIX SUTURE (ETHICON), AFTER WHICH A SIDE-TO-SIDE JEJUNOJEJUNOSTOMY IS CREATED WITH A 60-CM BILIOPANCREATIC LIMB BY USING THE SAME ECHELON FLEX 60 (ETHICON) AND AFTER STAPLING THE DEFECT IS CLOSED WITH SUTURE. IN THE EBS GROUP, REPORTED COMPLICATIONS INCLUDED ABDOMINAL HEMORRHAGE (N-2) AND OBSTRUCTION IN THE SMALL BOWEL CAUSED BY ADHESION (N-2). IN THE RESIDENT GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-2) AND SUTURE LEAKAGE (N-1). IN CONCLUSION, THE STEPWISE TRAINING PROGRAM RESULTS IN A FAST AND EFFICIENT WAY TO APPROACH THE LEARNING CURVE OF THE EXPERIENCED BARIATRIC SURGEONS. WITHIN THIS PROGRAM, THE TOTAL TIME OF THE OPERATION WILL BE KEPT LOW AND THE OPERATION WILL BE LESS INTENSIVE FOR THE PATIENTS. THE RESULTS OF THIS STUDY COULD ACT AS A GUIDELINE FOR THE DEVELOPMENT OF SUCH A TRAINING PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492070 STRATAFIX UNKNOWN SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention