BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONESTAR RETRACTOR

    MDR report key: 16974378 · Received May 22, 2023

    Report

    Report Number
    1216677-2023-00084
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    January 1, 2017
    Report Date
    July 21, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAD
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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: FOREIGN: MOROCCO. G2: LITERATURE: (PERINEAL SKIN RECURRENCE ON THE SITE OF LONE STAR RETRACTOR: CASE REPORT, HAMID ET AL, 2017). DISTRIBUTION HISTORY: DISTRIBUTION HISTORY CANNOT BE PROVIDED AS THERE IS NO LOT NUMBER. MANUFCTRNG 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 COOPERSURGICAL. FUNCTIONAL EVAL.: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. 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). COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    AS REVIEWED IN - HAMID ET AL. SURGICAL CASE REPORTS (2017) DOI 10.1186/S40792-017-0405-0. ABSTRACT (PERINEAL SKIN RECURRENCE ON THE SITE OF LONE STAR RETRACTOR: CASE REPORT, HAMID ET AL, 2017). "LOCAL RECURRENCE OF COLORECTAL CANCER IS A MAJOR CAUSE OF MORBIDITY AND MORTALITY THAT USUALLY IMPLIES A WORSE PROGNOSIS. ITS ETIOPATHOGENESIS IS STILL A SUBJECT OF DEBATE. RECURRENCE ON THE PERINEAL WOUND CAUSED BY ANAL RETRACTOR DEVICE IS RARELY REPORTED. CASE PRESENTATION: WE PRESENT THE CASE OF A 75-YEAR-OLD WOMAN WITH PERINEAL SKIN RECURRENCE ON THE SITE OF LONE STAR RETRACTOR¿ FROM RECTAL ADENOCARCINOMA. THE PATIENT UNDERWENT A CURATIVE PROCTECTOMY FOLLOWED BY A HANDSEWN COLOANAL ANASTOMOSIS USING LONE STAR RETRACTOR¿ 2 YEARS AGO FOR A TUMOR OF THE LOWER RECTUM. THE RECURRENCE WAS MOST LIKELY CAUSED BY THE SEEDING OF EXFOLIATED TUMOR CELLS INTO THE PERIANAL SKIN WHICH WAS ABRADED BY THE RETRACTOR."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478506 LONESTAR RETRACTOR LONESTAR RETRACTOR GAD COOPERSURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other| L| R