BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINA BIPOLAR LOOP, LARGE

    MDR report key: 20492082 · Received October 21, 2024

    Report

    Report Number
    3007699067-2024-00001
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 26, 2024
    Manufacturer
    LINA MEDICAL APS
    Product Code
    HIN
    UDI-DI
    05708265004638
    PMA / PMN Number
    K130305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DOCUMENTATION FOR PRODUCT BL-200 2310021 WAS REVIEWED AND NO DEVIATIONS WERE NOTED DURING THE MANUFACTURING AND INSPECTION PROCESSES. THE COMPONENT THAT BROKE WAS THE FIBRE TUBE, THE INDEX BEFORE LOGO IMPRINTING WAS R-0978 (AFTER IMPRINTING WHICH IS A PROCESS THAT TAKES PLACE AT LINA MEDICAL FROM 2021 IS H-1284). THE R-0978 COMPONENT HAS NOT CHANGED SINCE 2021. IN ADDITION, THE BATCHES OF COMPONENT R-0978 USED IN THE PRODUCTION OF THE FINISHED PRODUCT (R-0978 220321-071 AND 221125-17) WERE RELEASED WITHOUT ANY NON-CONFORMITIES AFTER INCOMING INSPECTION. THE IFU FV0137K FOR THE LINA BIPOLAR LOOP PRODUCT ASSUMES INSPECTION FOR DEFECTS, HOWEVER, WE RECEIVED NO INFORMATION THAT THE PRODUCT HAD DEFECTS PRIOR TO USE. THE INSTRUCTIONS RECOMMEND GENERATOR SETTINGS OF 55-70 W (WITH A RECOMMENDATION TO USE THE LOWEST SETTINGS) THE USE OF GRASPERS AND UTERINE MANIPULATORS TO FACILITATE ELECTRODE PLACEMENT AROUND THE UTERINE BODY OR MYOMA IS PERMITTED. WE WERE NOT INFORMED WHAT ADDITIONAL DEVICES WERE USED DURING THE SURGERY. FURTHERMORE, THE HOSPITAL DID NOT INFORM US ABOUT THE SEQUENCE OF EVENTS OR THE GENERATOR SETTINGS. THE INFORMATION OBTAINED IS VERY LACONIC AND DOES NOT ALLOW US TO DETERMINE THE CAUSE OF THE EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE HOSPITAL PROVIDED SEVERAL PHOTOGRAPHS SHOWING SIGNIFICANT DAMAGE TO THE TUBE INSIDE THE ABDOMINAL CAVITY. WE DID NOT RECEIVE CLEAR INFORMATION ON THE PATIENT'S CONDITION. WE REVIEWED THE RISK ANALYSIS. AS A RESULT, WE ADDED THE RISKS ASSOCIATED WITH TUBE DAMAGE.

    Additional Manufacturer Narrative · 0

    AT THE DAY OF INITIAL REPORT PROVIDED, THE DHR DOCUMENTATION FOR PRODUCT BL-200 BATCH 2310021 WAS REVIEWED AND TURNED OUT THAT THERE IS NO DEVIATION DURING ASSEMBLY AND MANUFACTURING PROCESS WHICH COULD HAVE THE IMPACT OF DEVICE MALFUNCTION. INFORMATION ABOUT INCIDENT WE RECEIVED ON 23.09.2024 FROM LINA'S MEDICAL US WHICH IS THE LINA MEDICAL APS DISTRIBUTOR (B)(4). IN COMPLAINT FORM FOR THIS CASE STATED THAT DEVICE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    INFORMATION WHICH WAS PROVIDED TO LINA MEDICAL BY US DISTRIBUTOR: "PRODUCT BROKE INSIDE OF PT, PIECES RECOVERED BY SURGEON". "ALL VISIBLE FRAGMENTS WERE REMOVED, CAVITY IRRIGATED AND ASPIRATED".

    Description of Event or Problem · 0

    INFORMATION WHICH WERE PROVIDED TO LINA MEDICAL BY US DISTRIBUTOR: "PRODUCT BROKE INSIDE OF PT, PIECES RECOVERED BY SURGEON." "ALL VISIBLE FRAGMENTS WERE REMOVED, CAVITY IRRIGATED AND ASPIRATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043474 LINA BIPOLAR LOOP, LARGE LINA BIPOLAR LOOP, LARGE HIN LINA MEDICAL APS BL-200 2310021 05708265004638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R GENERATOR LIGASURE SH31959.| GENERATOR LIGASURE SH31959.