BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR FORCEPS, UNSPECIFIED

    MDR report key: 7507301 · Received May 11, 2018

    Report

    Report Number
    2523190-2018-00069
    Event Type
    Injury
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNAVAILABLE, HENCE THE APPLICABLE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE COMPLAINT IS NOT CONFIRMED. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENTS IS EXPECTED TO BE RETURNED FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4). LINKED TO MFG. REPORT NUMBERS: 3006697299-2018-00025, 3006697299-2018-00026, AND 2523190-2018-00070. HTTPS://DOI.ORG/10.1016/J.HPB.2017.10.006.

    Description of Event or Problem · 1

    HPB (2018) PUBLISHED ¿FULLY LAPAROSCOPIC LEFT HEPATECTOMY-A TECHNICAL REFERENCE PROPOSED FOR STANDARD PRACTICE COMPARED TO THE OPEN APPROACH: A RETROSPECTIVE PROPENSITY SCORE MODEL¿ IN WHICH IT DISCUSSED THE SAFETY AND EFFECTIVENESS OF THE LAPAROSCOPIC LEFT HEMIHEPATECTOMY (LLH) TECHNIQUE DEVELOPED AT HENRI MONDOR HOSPITAL SINCE 1996. A SINGLE-SERIES, RETROSPECTIVE PAIR-MATCHED SAFETY/EFFICACY STUDY WAS PERFORMED, COMPARING (LLH) WITH OPEN LEFT HEMIHEPATECTOMY (OLH). THE ANALYSIS COVERED 17 LLH AND 51 OLH PERFORMED FROM 1996 TO 2014. FOR THE LLH, THREE COAGULATION DEVICES WERE UTILIZED: HARMONIC ACE (ULTRACISION, ETHICON ENDO-SURGERY), LIGASURE (COVIDIEN) AND A BIPOLAR FORCEPS (MICROFRANCE) AND ONE ULTRASONIC DISSECTOR (CUSA, INTEGRA). RESULTS: TWO (2) LLH WERE CONVERTED TO OPEN: ONE HAD A TUMOR THROMBUS FOUND INTRAOPERATIVELY IN THE PORTAL VEIN AND AFTER COMPLETION OF SURGERY, THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THE SECOND DEVELOPED HYPOXEMIA DUE TO CO2 EMBOLISM SECONDARY TO LEFT HEPATIC VEIN INJURY AND THE POSTOPERATIVE COURSE WAS UNEVENTFUL. COMPLICATIONS OBSERVED IN FIVE (5) LLH WERE AS FOLLOWS: 1. COMPLICATION: BILIARY LEAK/COLLECTION, CLAVIENDINDO: IIIB, FIBROSIS: 3, STEATOSIS: 5, TREATMENT: LAPAROTOMY, HOSPITAL STAY: 16, DIAGNOSIS: BILIARY CYST 2. COMPLICATION: PNEUMONIA, CLAVIENDINDO: II, FIBROSIS: 1, STEATOSIS: 30, TREATMENT: ANTIBIOTICS, HOSPITAL STAY: 9, DIAGNOSIS: HEPATOCELLULAR CARCINOMA (HCC) 3. COMPLICATION: RESPIRATORY FAILURE, CLAVIENDINDO: II, FIBROSIS: 1, STEATOSIS: 30, TREATMENT: NON-INVASIVE VENTILATION (NIV), HOSPITAL STAY: 7, DIAGNOSIS: HCC 4. COMPLICATION: PNEUMONIA, CLAVIENDINDO: II, FIBROSIS: 4, STEATOSIS: 0, TREATMENT: ANTIBIOTICS, HOSPITAL STAY: 10, DIAGNOSIS: INTRAHEPATIC LITHIASIS 5. COMPLICATION: PULMONARY FAILURE, CLAVIENDINDO: IVA, FIBROSIS: 4, STEATOSIS: 15, TREATMENT: INVASIVE VENTILATION (IV), HOSPITAL STAY: 12, DIAGNOSIS: HCC CONCLUSION: THE TECHNIQUE IS RECOMMENDED AS A POSSIBLE TECHNICAL REFERENCE FOR STANDARD LLH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351814 BIPOLAR FORCEPS, UNSPECIFIED BIPOLAR FORCEPS GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HARMONIC ACE (ETHICON)| LIGASURE (COVIDIEN)| HARMONIC ACE (ETHICON)| LIGASURE (COVIDIEN)