BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15753811 · Received November 8, 2022

    Report

    Report Number
    3005075853-2022-07672
    Event Type
    Death
    Date Received
    November 8, 2022
    Date of Event
    January 13, 2021
    Report Date
    November 8, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2021. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: MINIMALLY INVASIVE ESOPHAGECTOMY THE STANDARD OF CARE: EXPERIENCE FROM A TERTIARY CARE CANCER CENTER FROM INDIA. AUTHOR: RAO T. SUBRAMANYESHWAR1 & K. V. V. N. RAJU1 & SUJIT CHYAU PATNAIK1 & AJESH RAJ SAKSENA1 & REDDY R. PRATAP1 & BASANTH KUMAR RAYANI2 & VIBHAVARI MILIND NAIK2 & SYED NUSRATH1. CITATION: INDIAN JOURNAL OF SURGICAL ONCOLOGY HTTPS://DOI.ORG/10.1007/S13193-021-01291-. THIS RETROSPECTIVE STUDY AIMS TO REVIEW THE AUTHOR EXPERIENCE IN MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) AND ANALYZE THE ADEQUACY OF THE PROCEDURE AND ITS SHORT- AND LONG-TERM OUTCOMES. FROM JANUARY 2010 TILL DECEMBER 2016, 459 PATIENTS WITH RESECTABLE CARCINOMA ESOPHAGUS AND GASTRO-ESOPHAGEAL JUNCTION UNDERGOING ESOPHAGECTOMY AT BASAVATARAKAM INDO AMERICAN CANCER HOSPITAL, A TERTIARY CANCER CARE CENTER AT HYDERABAD, INDIA, WERE REVIEWED. PATIENTS (N = 459) WERE STRATIFIED INTO TWO GROUPS BASED ON THE APPROACH INTO MINIMALLY INVASIVE TRANSHIATAL ESOPHAGECTOMY (MI-THE) AND MINIMAL INVASIVE TRANSTHORACIC ESOPHAGECTOMY TTE (MI-TTE). TWO HUNDRED SEVENTY-EIGHT PATIENTS (278) , 146 MALES AND 132 FEMALES , AGE 53 (22¿82 YEARS ) UNDERWENT TRANSHIATAL RESECTION (MI-THE), AND 181 , 78 MALES AND 103 FEMALES , AGE 50(22¿77 YEARS) TRANSTHORACIC RESECTIONS (MI-TTHE). DURING SURGERY, IN MINIMALLY INVASIVE TRANSHIATAL ESOPHAGECTOMY (MI-THE) GROUP AFTER ESOPHAGECTOMY, A 3 TO 3.5 CM WIDE GASTRIC TUBE IS CREATED WITH INTERRUPTED PDS 2¿0 SUTURES OR STAPLERS. WHILE IN MINIMAL INVASIVE TRANSTHORACIC ESOPHAGECTOMY TTE (MI-TTE) GROUP, A CUT IS MADE ON VISCERAL PLEURA COVERING THE ESOPHAGUS AND LUNG WITH THE HARMONIC SCALPEL (ETHICON ENDO-SURGERY, INDIA) AND EXTENDED CRANIALLY AND CAUDALLY IN LINE WITH THE ESOPHAGUS. FOLLOW-UP EXTENDED FROM 35 TO 118 MONTHS WITH A MEDIAN OF 76 MONTHS. REPORTED COMPLICATIONS INCLUDED: MINIMALLY INVASIVE TRANSHIATAL ESOPHAGECTOMY (MI-THE): (N=14) PATIENTS DEVELOPED ANASTOMOTIC LEAKAGE OF WERE CAUSED BY CONDUIT TIP NECROSIS (=2) REQUIRING EXPLORATION AND RE-ANASTOMOSIS. THE REST OF THE ANASTOMOTIC LEAKS SETTLED WITH CONSERVATIVE MANAGEMENT. (N=3) OUT OF 5 CASES OF CONDUIT BLEED INMINIMALLY INVASIVE TRANSHIATAL ESOPHAGECTOMY (MI-THE) ARM REQUIRED RE-EXPLORATION. (N=1) CHYLE LEAK OCCURRED WHICH WAS SETTLED WITH CONSERVATIVE MANAGEMENT.(N=10) LATE ANASTOMOTIC STRICTURE RATES (N=1) INTESTINAL OBSTRUCTION .(N=1) PERI-FJ LEAK .(N=17) SSS . MINIMAL INVASIVE TRANSTHORACIC ESOPHAGECTOMY TTE (MI-TTE): (N=1) (DEATH) THERE WAS ONE MAJOR BLEED FROM A PULMONARY VEIN IN A PATIENT FROM MI-TTE ARM, WITH AN ESTIMATED BLOOD LOSS OF 3000 ML BEFORE IT WAS CONVERTED TO THORACOTOMY AND CONTROLLED. HE SUCCUMBED TO REFRACTORY HYPOTENSION AND DISSEMINATED INTRAVASCULAR COAGULATION AND DIED 6 H AFTER SURGERY. (N=1) DEATH POST-OPERATIVE DAY 5 DUE TO PYLOROMYOTOMY LEAK AND SEPSIS.(N=1) TRACHEOBRONCHIAL INJURIES OCCURRED .ALL WERE IDENTIFIED AND REPAIRED ON THE TABLE.A TOTAL OF 9 PATIENTS IN MI-TTE ARM DEVELOPED ANASTOMOTIC LEAKAGE OF WHICH 2 IN MI-TTHE ARM WERE CAUSED BY CONDUIT TIP NECROSIS REQUIRING EXPLORATION AND RE-ANASTOMOSIS. THE REST OF THE ANASTOMOTIC LEAKS SETTLED WITH CONSERVATIVE MANAGEMENT.ONE OF CONDUIT BLEED IN MI-TTE ARM REQUIRED RE-EXPLORATION. TWO PATIENTS IN MI-TTE HAD PERICARDIAL EFFUSION. REST OF THE PATIENTS WERE MANAGED CONSERVATIVELY AND RECOVERED UNEVENTFULLY.CHYLE LEAK OCCURRED IN 2 PATIENTS IN MI-TTHE SETTLED WITH CONSERVATIVE MANAGEMENT.(N=10) LATE ANASTOMOTIC STRICTURE RATES (N=5) SSS .(N=1) INTESTINAL OBSTRUCTION. (N=5) PLEURAL EFFUSIONS. IT WAS CONCLUDED , THAT MINIMALLY INVASIVE ESOPHAGECTOMY EITHER BY TRANSHIATAL OR TRANSTHORACIC APPROACH IS FEASIBLE AND CAN BE SAFELY ACCOMPLISHED WITH A LOW MORBIDITY AND MORTALITY AND WITH SATISFACTORY R0 RESECTION RATES, GOOD NODAL HARVEST, AND ACCEPTABLE LONG-TERM ONCOLOGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227671 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death HANDPIECE AND GENERATOR