BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18708273 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01397
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    March 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: VOLUME 2021, ARTICLE ID 6676999, 10 PAGES/ HTTPS://DOI.ORG/10.1155/2021/6676999.

    Description of Event or Problem · 0

    TITLE: CLINICAL APPLICATION OF A MODIFIED DOUBLE PURSE-STRING CONTINUOUS SUTURE TECHNIQUE FOR PANCREATICOJEJUNOSTOMY: RELIABLE FOR LAPAROSCOPIC SURGERY AND SMALL SIZE MAIN PANCREATIC DUCT THE AIM OF THE STUDY WAS TO PRESENT AN EASY-TO-MASTER PANCREATOJEJUNOSTOMY (PJ) ANASTOMOSIS TECHNIQUE WITH LIMITED TECHNICAL REQUIREMENTS. THIS TECHNIQUE USES TWO LAYERS OF SUTURES AND DOUBLE PURSE-STRING SUTURES TO COMPLETE THE ENTIRE ANASTOMOSIS. FEBRUARY 2015 TO AUGUST 2020, 63 PATIENTS (44 MEN AND 19 WOMEN WITH THE MEAN AGE OF 60.4 YEARS) WHO MET THE SURGICAL INDICATIONS UNDERWENT A MODIFIED DOUBLE PURSE-STRING CONTINUOUS SUTURE PANCREATICOJEJUNOSTOMY TECHNIQUE IN THE CENTER. THIRTY-EIGHT PATIENTS UNDERWENT LAPAROSCOPIC SURGERY (LS) AND 26 PATIENTS HAD A SMALL MAIN PANCREATIC DUCT (MPD) (<3 MM). 4-0 NONABSORBABLE SUTURE (PROLENE, ETHICON) WAS USED TO PERFORM PURSE-STRING SUTURING AT THE PANCREATIC STUMP. REPORTED COMPLICATION ARE DELAYED GASTRIC EMPTYING, POST-OPERATIVE HEMORRHAGE, RESPIRATORY EVENTS, SURGICAL WOUND INFECTION, BILE LEAKAGE, ABDOMINAL INFECTIONS AND CARDIAC EVENTS. IN CONCLUSION, THIS NEW TECHNIQUE CAN NOT ONLY REDUCE THE INCIDENCE OF POPF BUT ALSO IS RELIABLE FOR LS AND SURGERIES WITH SMALL SIZE MPD. THEREFORE, THIS TECHNIQUE IS WORTHY OF CLINICAL PROMOTION AND APPLICATION IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765225 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention