BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7429127 · Received April 13, 2018

    Report

    Report Number
    2210968-2018-72127
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT ENDOLOOP OR PDS SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: CAN J SURG, VOL. 55, NO. 1, FEBRUARY 2012. [(B)(4)-SAFAVI 2012 (3).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: ENDOLOOP VERSUS ENDOSTAPLER CLOSURE OF THE APPENDICEAL STUMP IN PEDIATRIC LAPAROSCOPIC APPENDECTOMY. AUTHORS : ARASH SAFAVI, MD, MONICA LANGER, MD, ERIK D. SKARSGARD, MD. DOI: 10.1503/(B)(4). CITATION: CAN J SURG, VOL. 55, NO. 1, FEBRUARY 2012. THE AIM OF THIS STUDY WAS TO COMPARE INFECTIOUS OUTCOMES BETWEEN 2 LAPAROSCOPIC TECHNIQUES OF APPENDICEAL STUMP CLOSURE: ENDOLOOP (EL) AND ENDOSTAPLER (ES). A TOTAL OF 242 PATIENTS UNDERWENT LA DURING THE STUDY PERIOD AND HAD COMPLETE DATA SETS ABSTRACTED RETROSPECTIVELY FROM THEIR MEDICAL RECORDS. THE PATIENT WERE DIVIDED INTO 2 GROUPS: NON-PERFORATED APPENDICITIS (NPA) N=185, PERFORATED APPENDICITIS (PA) N=57. ONE SURGEON USED THE ES (ETHICON ENDOSURGERY) IN ALL CASES (PA AND NONPERFORATED APPENDICITIS [NPA]) WHEREAS 2 SURGEONS ROUTINELY USED EL UNLESS THE CONDITION OF THE APPENDICEAL BASE FAVOURED USE OF AN ES TO ENSURE SEALING OF HEALTHY TISSUE. ENDOLOOP STUMP CLOSURE CONSISTED OF 2 PROXIMAL AND 1 DISTAL 2¿0 POLYDIOXANONE (PDS; ETHICON) ELS, WITH DIVISION OF THE APPENDICEAL BASE BETWEEN THE MIDDLE AND DISTAL EL. SURGICAL SITE INFECTIONS (NPA (N=2); PA (N=2)) AND INTRA-ABDOMINAL ABSCESS FORMATION (NPA (N=5); PA (N=6) WITH THE USE OF EL WERE REPORTED. INTRA-ABDOMINAL ABSCESS FORMATION (N=5) WITH THE USE OF ENDOSTAPLER WAS ALSO REPORTED. IN CONCLUSION, THIS STUDY SUGGESTS THAT PREFERENTIAL USE OF EL FOR APPENDICEAL STUMP CLOSURE IN LA IS ASSOCIATED WITH AT LEAST EQUIVALENT INFECTIOUS OUTCOMES, AS WELL AS COST SAVINGS, IN COMPARISON TO ROUTINE USE OF ES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270641 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention