BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15681794 · Received October 27, 2022

    Report

    Report Number
    2210968-2022-08849
    Event Type
    Injury
    Date Received
    October 27, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL ENDOSCOPY HTTPS://DOI.ORG/10.1007/S00464-022-09397-2.

    Description of Event or Problem · 0

    TITLE: REPRODUCTION OF MODIFIED BLUMGART PANCREATICOJEJUNOSTOMY IN A ROBOTIC ENVIRONMENT: A SIMPLE CLIPLESS TECHNIQUE. IN THIS STUDY, THE AUTHOR'S PROPOSE A SIMPLE TECHNIQUE TO REPRODUCE THE MODIFIED BLUMGART ANASTOMOSIS (MBA) IN ROBOTIC PANCREATICODUODENECTOMY (RPD) BASED ON OUR UNDERSTANDING OF THE ADVANTAGES AND LIMITATIONS OF THE ROBOTIC ENVIRONMENT AND EVALUATED ITS FEASIBILITY AND EFFICACY VERSUS THAT OF ORDINARY OPEN RECONSTRUCTION. FROM JANUARY TO DECEMBER IN 2021, 16 PATIENTS UNDERWENT OUR NOVEL ROBOTIC MBA TECHNIQUE, WHICH INCLUDED CLIPLESS BLUMGART SUTURE AND DUCT-TO-MUCOSA ANASTOMOSIS. TO SIMPLIFY THE MANIPULATION OF SUTURES IN ROBOTIC ENVIRONMENT, SHORT DOUBLE-ARMED SUTURES IN 15 CM LENGTH WERE CREATED AND USED FOR BLUMGART SUTURE. DUCT-TO-MUCOSA ANASTOMOSIS WERE DONE BY 5-0 MONOFILAMENT OF 6 CM LENGTH. THESE TIPS ENABLED CLIPLESS ANASTOMOSIS AND MINIMIZED THE BURDEN OF THE PATIENT-SIDE ASSISTANT. SURGICAL AND SHORT-TERM OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH ROBOTIC MBA (ROBO GROUP) AND THOSE WHO UNDERWENT OPEN MBA DURING 2021 (32 PATIENTS, OPEN GROUP). 5-0 ABSORBABLE SINGLE-ARMED MONOFILAMENT 6 CM LONG (PURPLE, PDS-II, ETHICON, US) WAS USED. REPORTED COMPLICATIONS INCLUDED CLAVIEN DINDO GRADE IIIA (N=9), PERCUTANEOUS DRAINAGE OF ABSCESS (N=2), POSTOPERATIVE PANCREATIC FISTULA (N=4), EXTRA-ABDOMINAL BLEEDING (N=1) , BOWEL OBSTRUCTION (N=1) IN CONCLUSION CLIPLESS MBA IN A ROBOTIC ENVIRONMENT WAS SAFELY PERFORMED WITH ACCEPTABLE SHORT-TERM OUTCOMES AND CAN BE PROPOSED AS A STANDARD TECHNIQUE FOR ROBOTIC PANCREATOJEJUNOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801991 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention