BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 16885257 · Received May 8, 2023

    Report

    Report Number
    3005075853-2023-03105
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    May 11, 2022
    Report Date
    May 8, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE IMPACT OF MULTIPLE FIRINGS ON THE RISK OF ANASTOMOTIC LEAKAGE AFTER MINIMALLY INVASIVE RESTORATIVE RECTAL CANCER RESECTION AND THE IMPACT OF ANASTOMOTIC LEAKAGE ON LONG-TERM SURVIVAL: A POPULATION-BASED STUDY AUTHORS: JACOB DAMGAARD ERIKSEN1,2,3 · KATRINE JØSSING EMMERTSEN3 · ANDERS HUSTED MADSEN4 · RUNE ERICHSEN3,5 · TROELS NØRGAARD BACHMANN1 · LENE HJERRILD IVERSEN1,2,6 CITATION: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2022); 37:1335¿1348. HTTPS://DOI.ORG/10.1007/S00384-022-04171-1 THE AIM OF THIS STUDY WAS TO EVALUATE THE ANASTOMOTIC LEAKAGE (AL) RATE AND PREDICTORS FOR AL FOLLOWING MINIMALLY INVASIVE RESTORATIVE RECTAL RESECTION (RRR) AMONG RECTAL CANCER PATIENTS MANAGED ACCORDING TO UP-TO-DATE STANDARDIZED TREATMENT. FURTHERMORE, THE AUTHORS EXPLORED THE IMPACT OF SYMPTOMATIC AL ON LONG-TERM SURVIVAL. A TOTAL OF 604 PATIENTS (403 MALE AND 202 FEMALE; MEDIAN AGE WAS 67 (35¿89) YEARS; MEDIAN BMI WAS 25.4 (15.7¿47.2) KG/M2) WITH RECTAL CANCER WHO UNDERWENT MINIMALLY INVASIVE RRR IN CENTRAL DENMARK REGION BETWEEN JANUARY 2013 AND OCTOBER 2017 WERE INCLUDED IN THE STUDY. THE STANDARD SURGICAL APPROACH WAS MINIMALLY INVASIVE WITH ROBOT-ASSISTED LAPAROSCOPY AS FIRST CHOICE. IN CASE OF LACK OF CAPACITY FOR ROBOT-ASSISTED SURGERY, LAPAROSCOPIC SURGERY WAS CONDUCTED. OPEN SURGERY WAS CONDUCTED IN CASE OF ADVANCED TUMOR REQUIRING RESECTION BEYOND THE MESORECTAL FASCIA AND WERE EXCLUDED IN THIS STUDY. TRANSANAL TOTAL MESORECTAL EXCISION WAS NOT IMPLEMENTED IN CANCER SURGERY AT THE DEPARTMENTS. ALL ANASTOMOSES WERE STAPLED, NOT HAND-SEWN. STAPLER (TYPE) USED FOR TRANSECTION OF DISTAL RECTUM INCLUDES: ENDOGIA (N=280), ROBOTIC (N=81), ENDOSCOPIC, NOT SPECIFIED (N=95), CONTOUR (N=89), THORACOABDOMINAL (N=35), OPEN, NOT SPECIFIED (N=14), NOT SPECIFIED (N=10). REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC LEAKAGE (N=28). IN CONCLUSION, THE PRESENT STUDY CONDUCTED IN THE MINIMALLY INVASIVE TECHNIQUE ERA WITH ROBOT-ASSISTED APPROACH DEMONSTRATES THAT THE RISK OF AL AFTER RRR CONTINUES TO BE A CHALLENGE. TO REDUCE THE AL RATE, MULTIPLE FIRINGS SHOULD BE AVOIDED WHEN TRANSECTING THE RECTUM WITH AN ENDOSCOPIC STAPLER. AL HAD A STATISTICAL NON-SIGNIFICANT NEGATIVE IMPACT ON LONG-TERM SURVIVAL, WHICH NEEDS TO BE ADDRESSED IN FUTURE STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726821 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention