BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONESTAR RETRACTOR

    MDR report key: 16948719 · Received May 17, 2023

    Report

    Report Number
    1216677-2023-00080
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    January 1, 2008
    Report Date
    July 13, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAD
    PMA / PMN Number
    K050256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE DETAILS OUTLINED IN THIS CASE REPORT AS PUBLISHED.

    Additional Manufacturer Narrative · 0

    G2: DISEASES OF THE COLON & RECTUM 51(12):P 1850-1852, DECEMBER 2008. / DOI: 10.1007/S10350-008-9338-9. HTTPS://JOURNALS.LWW.COM/DCRJOURNAL/ABSTRACT/2008/51120/CUTANEOUS_PERIANAL_RECURRENCE_ON_THE_SITE_OF_LONE.19.ASPX#CONTENT ACCESS OPTIONS. G2: FRANCE. DISTRIBUTION HISTORY: DISTRIBUTION HISTORY CANNOT BE PROVIDED AS THERE IS NO LOT NUMBER. MANUFACTURING RECORD REVIEW: LOT NUMBER NOT PROVIDED TO PERFORM DHR REVIEW. INCOMING INSPECT REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORIC COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS NOT RETURNED. VISUAL EVAL. EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. FUNCTIONAL EVAL. EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. RISK ANALYSIS: THE RISK OF CANCER CELL DISSEMINATION DID NOT MEET THE CRITERIA OF A SIGNIFICANT RESIDUAL RISK WHICH WOULD HAVE REQUIRED DISCLOSURE IN THE IFU. OVER THE PREVIOUS 5-YEAR SURVEILLANCE PERIOD, 2.5-3.5 MILLION ELASTIC STAYS ARE USED PER YEAR. THE INSTANCES OF CANCER CELL DISSEMINATION REPRESENTED BY 4 INSTANCES AMONG 2.5 MILLION USES IS ONLY (B)(4), WHICH STILL FALLS WITHIN AN OCCURRENCE OF IMPROBABLE (O1). COOPER SURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    AS REVIEWED IN - DISEASES OF THE COLON & RECTUM 51(12):P 1850-1852, (B)(6) 2008. / DOI: 10.1007/S10350-008-9338-9 CASE REPORT: "THE FIRST TWO CASES OF CUTANEOUS PERINEAL RECURRENCE ON THE SITE OF A LONE STAR RETRACTOR¿ AFTER HANDSEWN J-POUCH COLOANAL ANASTOMOSIS FOR RECTAL CANCER ARE PRESENTED. IN TWO CASES, RECURRENCE OCCURRED ON THE SCARS INDUCED BY ELASTIC STAY HOOK OF LONE STAR RETRACTOR. BOTH CASES WERE TREATED BY LOCAL EXCISION ALONE. AT ONE YEAR OF FOLLOW-UP, THERE WERE NO SIGNS OF LOCAL RECURRENCE.".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500321 LONESTAR RETRACTOR LONESTAR RETRACTOR GAD COOPERSURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O| H| L