BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55MM SELECTABLE NEW TLC

    MDR report key: 8703832 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19787
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2013
    Report Date
    May 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002611
    PMA / PMN Number
    K092577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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 THE ETHICON PRODUCTS USED IN THIS PROCEDURE? KINDLY PROVIDE THE SPECIFIC NUMBER OF PATIENTS WHO EXPERIENCED THE EVENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: MANAGEMENT OF COMPLICATIONS OF RADICAL ESOPHAGECTOMY. AUTHOR : SANJAY SHARMA. CITATION: INDIAN J SURG ONCOL (JUNE 2013) 4(2):105¿111 / DOI 10.1007/S13193-013-0215-1. THE PURPOSE OF THIS STUDY IS TO DESCRIBE MANAGEMENT OF COMPLICATIONS OF RADICAL ESOPHAGECTOMY AND TO PRESENT OUTCOME ANALYSIS OF PROSPECTIVE STUDY DONE ON PATIENTS WHO UNDERWENT RADICAL ESOPHAGECTOMY WITH 3 FIELD LYMPH NODE DISSECTION (FLND). THE STUDY WAS INITIATED ON 1997, A TOTAL OF 326 PATIENTS UNDERWENT RADICAL 3 FIELD ESOPHAGECTOMY WITH LYMPHADENECTOMY. THE PATIENTS WERE DIVIDED INTO THREE TIME PERIODS: PERIOD I [AUG 1997 ¿ DEC 2000] (N=100), PERIOD II [JAN 2001 ¿ DEC 2003] (N=88), PERIOD III [JAN 2004 ¿ DEC 2012] (N=138). IN ALL CASES, STOMACH TUBE WAS FASHIONED AS A CONDUIT USING NTLC 55 LINEAR CUTTER STAPLERS. HANDSEWN END TO SIDE TWO LAYERED ESOPHAGO GASTRIC ANASTOMOSIS WAS DONE IN NECK. THE PROXIMAL END OF STOMACH TUBE WAS WRAPPED ANTERIORLY TO CERVICAL ESOPHAGUS (SS TECHNIQUE). POSTOPERATIVE COMPLICATIONS INCLUDED LOCO REGIONAL RECURRENCE (N=9.7%), LEAK (N=2.4%), BLOOD LOSS (N=?), STRICTURES (N=5.3%), POSTOPERATIVE HEMORRHAGE (N=0.9%). RADICAL ESOPHAGECTOMY WITH 3 FLND IS A FORMIDABLE OPERATION WITH POTENTIAL TO IMPROVE SURVIVAL AND DECREASE LOCO REGIONAL RECURRENCES. THE COMPLICATIONS OF RADICAL ESOPHAGECTOMY MUST BE IDENTIFIED AND TREATED IN TIME. A CONSIDERABLE PROGRESS HAS BEEN MADE TO MANAGE COMPLICATIONS OF RADICAL ESOPHAGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497006 55MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036002611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention