BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12698496 · Received October 26, 2021

    Report

    Report Number
    2210968-2021-10334
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    October 16, 2020
    Report Date
    October 14, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. (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/S00464-020-08107-0.

    Description of Event or Problem · 0

    TITLE: A NOMOGRAM ILLUSTRATING THE PROBABILITY OF ANASTOMOTIC LEAKAGE FOLLOWING CERVICAL ESOPHAGOGASTROSTOMY. A RETROSPECTIVE SINGLE-CENTRE STUDY IN 412 CONSECUTIVE PATIENTS WHO HAD CERVICAL ESOPHAGOGASTROSTOMY FOLLOWING ESOPHAGECTOMY BETWEEN 1/2004 AND 12/2018. THE TUBULATED STOMACH WAS CREATED USING THE STAPLER DEVICE, THE WIDTH OF THE GASTRIC CONDUIT WAS DETERMINED WITH FIVE CENTIMETRES IN ORDER TO PREVENT POSTOPERATIVE BROADENING OF THE CONDUIT. THE STAPLE LINE WAS OVERSEWN USING INTERRUPTED ABSORBABLE, MONOFILIC 4/0 POLYDIOXANONE SUTURES (PDS®; ETHICON). FOR MANUAL ANASTOMOTIC SUTURING, A DOUBLE-LAYER POSTERIOR AND A SINGLE-LAYER ANTERIOR WALL TECHNIQUE USING INTERRUPTED MONOFILIC ABSORBABLE 4/0 POLYDIOXANONE SUTURES (PDS®; ETHICON). REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC DEHISCENCE (N=76), IN CONCLUSION BY USING THE NOMOGRAM AS A SUPPORTIVE MEASURE IN THE PERIOPERATIVE MANAGEMENT, THE PATIENT¿S INDIVIDUAL PROBABILITY OF DEVELOPING AN ANASTOMOTIC LEAK COULD BE QUANTIFIED WHICH MAY HELP TO TAKE PREVENTIVE MEASURES IMPROVING THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597221 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1