BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP

    MDR report key: 9529907 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24804
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2012
    Report Date
    December 4, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036002109
    PMA / PMN Number
    K990362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/ BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: EFFECTIVENESS OF USING ULTRASONICALLY ACTIVATED SCALPEL IN COMBINATION WITH RADIOFREQUENCY DISSECTING SEALER OR IRRIGATION BIPOLAR FOR HEPATIC RESECTION. AUTHOR : HIDEKI YOKOO, TOSHIYA KAMIYAMA, KAZUAKI NAKANISHI, MUNENORI TAHARA, DAISUKE FUKUMORI, HIROFUMI KAMACHI, MICHIAKI MATSUSHITA AND SATORU TODO. CITATION: HEPATO-GASTROENTEROLOGY 2012; 59:831-835 / DOI: 10.5754/ HGE10377. THE PURPOSE OF THIS STUDY WAS TO EXPLAIN WHETHER THE USE OF HARMONIC SCALPEL IN COMBINATION WITH TISSUE LINK DISSECTING SEALER (TLDC) 3.0 OR IRRIGATION BIPOLAR WAS AN EFFICIENT DEVICE FOR HEPATECTOMY AND TO DETERMINE WHICH OF THE THERMO-COAGULATION SYSTEMS, TLDC 3.0 OR IRRIGATION BIPOLAR, WAS MORE USEFUL IN TERMS OF SAFE EXECUTION OF LIVER PARENCHYMA TRANSECTION AND THE EFFECT ON THE REMNANT LIVER. BETWEEN JAN 1999 AND JAN 2006, A TOTAL OF 533 PATIENTS [N=358 MALE, N=175 FEMALE, MEDIAN AGE 57 YEARS (1-82 YEARS)] UNDERWENT HEPATECTOMY FOR LIVER TUMORS AND FOR LIVER TRANSPLANTATION. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: TL GROUP, PERFORMED USING ULTRASONICALLY ACTIVATED SCALPEL WITH A HOOK BLADE ALONG WITH A SALINE-LINKED RADIOFREQUENCY DISSECTING SEALER (N=215); OR IB GROUP, BIPOLAR CAUTERY WITH A SALINE-IRRIGATION SYSTEM (N=318). ALL HEPATECTOMY PROCEDURES WERE PERFORMED WITHOUT BILIARY AND GASTROINTESTINAL TRACT RECONSTRUCTIONS USING HOOK BLADE OF ULTRASONIC COAGULATING SHEARS (HARMONIC SCALPEL, ETHICON) IN COMBINATION WITH TERMO-COAGULATION DEVICES SUCH AS TLDC 3.0 OR IRRIGATION BIPOLAR. THE PRIMARY SURGEON STOOD AT THE RIGHT SIDE OF THE PATIENT AND DISSECTED THE HEPATIC PARENCHYMA USING THE HARMONIC SCALPEL WITH A HOOK BLADE AND SMALL-SIZED SUCTION INSTRUMENTS. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING (N=13) AND BILE LEAKAGE (N=35). IN CONCLUSION, THE METHOD OF PERFORMING HEPATIC PARENCHYMAL TRANSECTION USING ULTRASONICALLY ACTIVATED SCALPEL WITH A HOOK BLADE IN COMBINATION WITH TLDC 3.0 IS USEFUL IN OBTAINING SHORTER OPERATIVE TIME THAN IN COMBINATION WITH IRRIGATION BIPOLAR AND BOTH TERMO-COAGULATING DEVICES CONTRIBUTES TO LESSER DAMAGE TO THE REMNANT LIVER AFTER HEPATECTOMY. THUS, IT CAN BE CONSIDERED THAT HARMONIC SCALPEL WITH THERMO-COAGULATING DEVICES ARE USEFUL IN HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323846 HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036002109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention