BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20587001 · Received November 1, 2024

    Report

    Report Number
    2210968-2024-11383
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    July 22, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL ENDOSCOPY.38:5413¿5421 HTTPS://DOI.ORG/10.1007/S00464-024-11100-6.

    Description of Event or Problem · 0

    TITLE: ROBOTIC-ASSISTED ENDOSCOPIC ONLAY REPAIR (R-ENDOR) FOR CONCOMITANT VENTRAL HERNIAS AND DIASTASIS RECTI: INITIAL RESULTS AND SURGICAL TECHNIQUE. THE AIM OF THIS STUDY WAS TO DESCRIBE THE ADAPTATION OF ENDOR TO A ROBOTIC PLATFORM, TERMED R-ENDOR, TO REPORT INITIAL OUTCOMES ALONG WITH OTHER ESTABLISHED ROBOTIC SURGICAL APPROACHES. A TOTAL OF 15 PATIENTS UNDERGOING R-ENDOR FOR VENTRAL HERNIA REPAIR WITH DIASTASIS RECTI PLICATION WERE INCLUDED. THE MEDIAN AGE WAS 59 YEARS. ADDITIONAL FIXATION WITH A RUNNING MIDLINE PLICATING SUTURE, PERIPHERAL RUNNING SUTURES (FIG. 2B), AND/OR FIBRIN (VISTASEAL¿, ETHICON) GLUE (FIG. 2C) CAN BE USED TO HELP FIXATE THE MESH. PNEUMOPERITONEUM CO2 PRESSURE IS REDUCED FROM 10¿15 TO 3¿5 MMHG AND EXTRACORPOREAL PRESSURE CAN BE APPLIED ON UMBILICUS AS NECESSARY TO SECURE UMBILICAL STALK MIDLINE USING 2-0 VICRYL SUTURE WITH A SLIDING KNOT (FIG. 2D). A 19-FRENCH BLAKE® DRAIN (ETHICON, SOMERVILLE, NJ, USA) IS INTRODUCED TO THE SUBCUTANEOUS SPACE, THROUGH ONE OF THE LATERAL PORTS, AND REMOVED IN 10¿14 DAYS. THE REPORTED COMPLICATIONS HYPOESTHESIA (N=40), SEROMA (N=20), SURGICAL SITE INFECTIONS (N=1), AND RECURRENCE (N=1). IN CONCLUSION, MIDLINE VENTRAL HERNIAS ASSOCIATED TO DIASTASIS RECTI CAN BE MANAGED ROBOTICALLY BY ENDOR WITH SAFE AND CONSISTENT 90-DAY OUTCOMES IN A CAREFULLY SELECTED GROUP OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176205 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention