BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS SYNERGY CURVED BLADE

    MDR report key: 11663641 · Received April 14, 2021

    Report

    Report Number
    3005075853-2021-01982
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    November 15, 2018
    Report Date
    March 25, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036002802
    PMA / PMN Number
    K012176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/19/2021 B1, B2, H1.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2018. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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 · 1

    TITLE: POST ESOPHAGECTOMY DIAPHRAGMATIC HERNIA: A CASE REPORT OF A RARE CAUSE OF ACUTE RESPIRATORY DISTRESS. AUTHORS: VALÉRIE LAMONTAGNE, VALÉRIE LAFRENIÈRE-BESSI, ARTHUR VIEIRA, ÉRIC CHARBONNEAU, PAULA A. UGALDE, AND FRÉDÉRIC JACQUES. CITATION: JOURNAL OF CARDIOTHORACIC SURGERY (2018) 13:11, HTTPS://DOI.ORG/10.1186/S13019-018-0802-X. THIS IS A CASE REPORT ON A (B)(6)-YEAR-OLD POST-ESOPHAGECTOMY MALE PATIENT, IN THE EARLY POSTOPERATIVE PERIOD OF CARDIAC SURGERY, PRESENTED WITH ACUTE RESPIRATORY DISTRESS. AN EMERGENT SURGERY WAS PERFORMED TO REDUCE A GIANT DIAPHRAGMATIC HERNIATION. THE PATIENT HAD UNDERGONE 3 STENT CORONARY IMPLANTATION PROCEDURES IN THE PREVIOUS 6 MONTHS, PRESENTED TO THE HOSPITAL WITH PROGRESSIVE DYSPNEA AND RECURRENT CHEST PAIN. THE PATIENT¿S MEDICAL HISTORY WAS NOTED FOR ESOPHAGEAL CANCER TREATMENT THAT CONSISTED OF A RADICAL ESOPHAGECTOMY, GASTRIC PULL-UP FOLLOWED BY CHEMOTHERAPY AND RADIOTHERAPY. THE PATIENT UNDERWENT A DUAL VALVE REPLACEMENT PROCEDURE WITH A BIOPROTHESIS AORTIC VALVE. ON POSTOPERATIVE (PO) DAY 8, A RIGHT-SIDED CHYLOTHORAX WAS DIAGNOSED, AND TREATED WITH SIMPLE DRAINAGE AND LOW-FAT MEDIUM CHAIN TRIGLYCERIDES DIET. ON PO DAY 18, THE PATIENT EVOLVED WITH ACUTE RESPIRATORY DETERIORATION AND HYPOXEMIA. A CHEST COMPUTERIZED TOMOGRAPHY CONFIRMED THE PRESENCE OF A LARGE PORTION OF THE TRANSVERSE AND DESCENDING COLON IN THE LEFT HEMITHORAX WITH NO RADIOLOGICAL SIGN OF INTESTINAL NECROSIS. THE DIAPHRAGMATIC HERNIA MEASURED 15 CM AND FILLED THE WHOLE TRANSVERSE DIMENSION OF THE LEFT CHEST ON THE ANTERIOR-POSTERIOR VIEW. URGENT DIAPHRAGMATIC HERNIA REPAIR WAS INDICATED AND PERFORMED BY LAPAROSCOPY. A LARGE QUANTITY OF PERITONEAL ADHERENCES WAS TAKEN DOWN WITH HARMONIC SYNERGY BLADES (ETHICON) UNDER DIRECT VISION. A LARGE DIAPHRAGMATIC HERNIA WAS IDENTIFIED WITH A LARGE PORTION OF THE TRANSVERSE COLON AND OMENTUM WITHIN THE LEFT CHEST CAVITY. THE REPAIR OF THE HIATAL HERNIA WAS PERFORMED BY APPROXIMATING THE LEFT AND RIGHT PILLARS WITH NON-ABSORBABLE STITCHES. A COMPETITOR'S HERNIA GRAFT WAS PLACED SURROUNDING THE HIATUS. A PROLENE MESH (ETHICON) WAS USED TO CLOSE THE ANTERIOR SPACE. BOTH GRAFTS WERE FIXED WITH A COMPETITOR'S TACKER FIXATION DEVICE. THE FINAL RESULT WAS SATISFACTORY. THE PATIENT HAD POSTOPERATIVE ISCHEMIC COLITIS AND INTERSTITIAL ALVEOLAR LEFT LOWER LOBE INFILTRATE. THIS WAS MANAGED WITH A CONSERVATIVE TREATMENT BASED ON ANTIBIOTICS AND PARENTERAL NUTRITION. ONE YEAR AFTER DISCHARGE, THE PATIENT WAS READMITTED WITH INCREASED DYSPNEA. A RIGHT SIDED CHYLOTHORAX, SECONDARY TO CHRONICALLY INDWELLING CATHETER SYSTEM INFECTION, WAS DIAGNOSED. THE DRAINAGE SYSTEM WAS CHANGED, ANTIBIOTIC TREATMENT WAS GIVEN FOR 2 WEEKS AND THE PATIENT IS NOW DOING WELL. IN CONCLUSION, AN ACUTE TRANSHIATAL HERNIATION CAN CAUSE SERIOUS RESPIRATORY IMPAIRMENT; SURGICAL REPAIR SHOULD BE CONSIDERED IN SELECT PATIENTS OF CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565013 HS SYNERGY CURVED BLADE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. SNGCB 10705036002802

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening GENERATOR AND HANDPIECE.| GENERATOR AND HANDPIECE.