BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18705697 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01383
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    October 15, 2021
    Report Date
    February 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: LANGEN BECK'S ARCHIVES OF SURGERY (2021) 406:2891-2897; HTTPS://DOI.ORG/10.1007/S00423-021-02347-X.

    Description of Event or Problem · 0

    TITLE: A NOVEL ANASTOMOSIS TECHNIQUE FACILITATES PANCREATICOJEJUNOSTOMY IN TOTAL LAPAROSCOPIC PANCREATICODUODENECTOMY (WITH VIDEO) THIS STUDY DESCRIBES A NEW PANCREATICOJEJUNOSTOMY TECHNIQUE USING THREE SUTURES (TERMED THE "THREE SUTURES" PJ TECHNIQUE), WHICH FACILITATES PANCREATIC ANASTOMOSIS DURING TOTAL LAPAROSCOPIC PANCREATICODUODENECTOMY. BETWEEN (B)(6) 2019 AND (B)(6) 2020, 149 PATIENTS WHO UNDERWENT LAPAROSCOPIC PANCREATICODUODENECTOMY USING THE "THREE SUTURES" PANCREATICOJEJUNOSTOMY TECHNIQUE WERE RE INCLUDED IN THIS STUDY. THERE WERE 91 MALES AND 58 FEMALES WITH A MEAN AGE OF 60.48 ± 11.9 YEARS (RANGE, 54-69) AND A MEAN BMI OF 22.46±3.06 KG/M2. DURING THE PROCEDURE, THE ANASTOMOSIS WAS PERFORMED AS FOLLOWS: PANCREATIC DUCT STENTING TUBE WITH SIDE HOLES WAS PLACED, 3 SUTURES OF 4-0 PROLENE (ETHICON) WERE USED FOR THIS ANASTOMOSIS. THE FIRST NEEDLE WAS INSERTED AT THE UPPER EDGE OF THE PANCREAS REMNANT, AND A U-SHAPED SUTURE WAS MADE AROUND THE PANCREATIC DUCT. THE SECOND PROLENE SUTURE (ETHICON) WAS USED TO FIX THE INFERIOR MARGIN OF THE PANCREATIC STUMP AND THE SEROMUSCULAR LAYER OF THE JEJUNUM BY CONTINUOUS SUTURE. BY USING THE FIRST PROLENE SUTURE (ETHICON), A 270° HALF-PURSE-STRING SUTURE WAS MADE AROUND THE HOLE TO FIX THE PANCREATIC DUCT AND THE TISSUE OF THE JEJUNUM OPENING. THE THIRD PROLENE SUTURE (ETHICON) WAS USED TO FIX THE SUPERIOR MARGIN OF THE PANCREATIC STUMP AND THE JEJUNUM BY CONTINUOUS SUTURE. REPORTED COMPLICATIONS INCLUDED CLINICALLY RELEVANT POSTOPERATIVE PANCREATIC FISTULA (N=14), BILE LEAKAGE (N=4), INTRA-ABDOMINAL ABSCESS (N=15), INTRA-ABDOMINAL HEMORRHAGE (N=6) WHICH WAS MAINLY CAUSED BY PSEUDOANEURYSM OF THE GASTRODUODENAL ARTERY (3 CASES) AND BLEEDING FROM THE STUMP OF GASTROEPIPLOIC VEINS (2 CASES), AND UPPER GASTROINTESTINAL BLEEDING (N=6), AND UNSPECIFIED COMPLICATIONS REQUIRING REOPERATION (N=3). IN CONCLUSION, THE "THREE SUTURES" PANCREATICOJEJUNOSTOMY TECHNIQUE FOR TOTAL LAPAROSCOPIC PANCREATICODUODENECTOMY IS A SAFE AND RELIABLE METHOD, WITH A LOW RISK OF PANCREATIC FISTULA, SHORT ANASTOMOSIS TIME, AND STEEP LEARNING CURVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424467 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention