BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONESTAR RETRACTOR

    MDR report key: 16461613 · Received March 1, 2023

    Report

    Report Number
    1216677-2023-00040
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 15, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAD
    PMA / PMN Number
    K050256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE DETAILS OUTLINED IN THIS CASE STUDY AS PUBLISHED IN VAN LIESHOUT ET AL., 2022. (MEDICAL DEVICE LITERATURE).

    Additional Manufacturer Narrative · 0

    UPDATED: A2, A3, B6, B7, G2 CORRECTION: H1 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 0.00016%, 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 VAN LIESHOUT ET AL., 2022 MEDICAL DEVICE LITERATURE THE CASE STUDY DISCUSSES A REOCCURRENCE OF RECTAL CANCER AFTER USE OF LONE STAR RETRACTOR. A 57 YEAR OLD MALE WAS DIAGNOSED WITH A HIGH RISK EARLY STAGE RECTAL ADENOCARCINOMA. HE WAS TREATED WITH TRANSANAL MINIMALLY INVASIVE SURGERY (TAMIS) WITH THE USE OF A LONE STAR RETRACTOR AND HE RECEIVED SUBSEQUENT CHEMO-RADIOTHERAPY. 23 MONTHS LATER THE PATIENT DEVELOPED A BLEEDING MASS BULGING OUT OF THE ANUS. A TRUE CUT AND INCISION BIOPSY WAS PERFORMED AND THE PATHOLOGY REPORT REVEALED LOCALIZATION OF ADENOCARCINOMA AT THE ANAL CANAL WHICH WAS SIMILAR TO THE EARLIER DIAGNOSED RECTAL CARCINOMA. THE PATIENT UNDERWENT AN ABDOMINAL PERINEAL RESECTION AND LEFT-SIDED LYMPH NODE DISSECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435275 LONESTAR RETRACTOR LONESTAR RETRACTOR GAD COOPERSURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| O