BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20597987 · Received November 4, 2024

    Report

    Report Number
    2210968-2024-11428
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    January 13, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATIONS : . BMC SURGERY. 24:22, PAGES : 1-9. HTTPS://DOI.ORG/10.1186/S12893-023-02308-9.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE : A MODIFIED BLUMGART METHOD USING A HOMEMADE CROCHET NEEDLE FACILITATES PANCREATICOJEJUNOSTOMY IN LAPAROSCOPIC PANCREATICODUODENECTOMY: A RETROSPECTIVE COHORT STUDY THE AIM OF THIS STUDY WAS TO INTRODUCE OUR MODIFIED BLUMGART APPROACH TO SECURE THESE STRUCTURES WITH ADJUSTABLE ADHESIONS USING A HOMEMADE CROCHET NEEDLE IN LPD. FROM FEBRUARY 2019 TO OCTOBER 2022, 96 LPD SURGERIES WITH THE NEW TECHNIQUE WERE PERFORMED BY THE SAME SURGEONS IN THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE. THERE WERE 54 MEN AND 42 WOMEN WITH A MEAN AGE OF 63.38±10.41 YEARS. A LARGE 4-0 PROLENE SUTURING NEEDLE WAS USED TO VERTICALLY ENTER THE PANCREAS STUMP 1 CM FROM THE VENTRAL SIDE, EXTENDING OUT FROM THE DORSAL SIDE OF THE EDGE OF THE PANCREAS. THE POSTERIOR SEMICIRCLE SUTURES OF THE DTM WERE PLACED AT THE 4, 6, AND 8 O¿CLOCK POSITIONS USING 5-0 PDS II (ETHICON INC, SOMERVILLE, NJ, USA). THE REPORTED COMPLICATIONS INCLUDED GRADE B POSTOPERATIVE PANCREATIC FISTULA (N=14), POSTOPERATIVE ABDOMINAL HEMORRHAGE (N=1), CHYLOUS FISTULA (N=6), DELAYED GASTRIC EMPTYING (N=4), BILE LEAKAGE (N=2), ABDOMINAL INFECTION (N=2), AND GASTROINTESTINAL ANASTOMOTIC HEMORRHAGE (N=1). IN CONCLUSION, A MODIFIED BLUMGART METHOD USING A HOMEMADE CROCHET NEEDLE COULD BE TECHNICALLY FEASIBLE AND SAFE DURING LPD. A RANDOMIZED CONTROL TRIAL IS NEEDED TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631411 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention