BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DV8 ESOPHAGEAL RETRACTOR

    MDR report key: 7054650 · Received November 22, 2017

    Report

    Report Number
    3011596926-2017-00002
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 25, 2016
    Report Date
    November 22, 2017
    Manufacturer
    MANUAL SURGICAL SCIENCES, LLC
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DV8 RETRACTOR IS A CLASS I 510K EXEMPT DEVICE UNDER PRODUCT CODE GAD (RETRACTOR) WHICH FALLS UNDER REGULATION 21 CFR 878.4800 AS A "MANUAL SURGICAL INSTRUMENT FOR GENERAL USE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON COMPLETION OF A PVI PROCEDURE WITH GENERAL ANESTHESIA ON (B)(6) 2016, THE PATIENT EXPERIENCED BLEEDING. THE DV8 DEVICE WAS EMPLOYED TO LATERALLY DISPLACE THE ESOPHAGUS, HOWEVER, ESOPHAGEAL INTUBATION WAS REPORTEDLY DIFFICULT. IMMEDIATELY POST PROCEDURE, PRIOR TO EXTUBATION, THERE WAS BLOOD NOTED IN THE OROPHARYNX. THE HOSPITAL GASTROINTESTINAL DEPARTMENT WAS CONSULTED, AND AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED. NO ABNORMALITIES OR BLEEDING WERE IDENTIFIED, BUT 2 CM PROXIMAL TO THE UPPER ESOPHAGEAL SPHINCTER, THERE WAS A SMALL HEMATOMA WITH NO ACTIVE BLEEDING. THE HOSPITAL EAR NOSE AND THROAT DEPARTMENT WAS ALSO CONSULTED, AND A FLEXIBLE LARYNGOSCOPY AND DIRECT LARYNGOSCOPY WERE BOTH PERFORMED. THIS REVEALED A SMALL (1.5-2 CM) LINEAR LACERATION SEEN AT MIDLINE IN THE POSTERIOR OROPHARYNX WITH SLOW ACTIVE BLEEDING CONTROLLED WITH SILVER NITRATE AND SURGICEL. THE SURGICEL WAS REMOVED WITH NO PACKING LEFT AND HEMOSTATIS WAS OBTAINED. THE PATIENT REMAINED INTUBATED FOR 2 DAYS, AND WAS EXTUBATED WITH PERIDEX ORAL RINSES THREE TIMES DAILY (INTUBATION WAS PARTLY DUE TO THE PRE-EXISTING LUNG DISEASE, PER THE PHYSICIAN). THE HOSPITALIZATION COURSE WAS COMPLICATED BY CHOLECYSTITIS, AND THE PATIENT REQUIRED A LAPAROSCOPIC CHOLECYSTECTOMY WITHOUT COMPLICATION ON THE 7TH POST-OPERATIVE DAY. THE PATIENT ALSO EXPERIENCED THROMBOCYTOPENIA AND A PULMONARY EMBOLISM ON THE 10TH POST-OPERATIVE DAY (RELATED TO HEPARIN INDUCED THROMBOCYTOPENIA). THE PATIENT WAS TREATED WITH IV ARGATROBAN UNTIL THE WARFARIN REACHED AN INR GREATER THAN 2. THE PATIENT WAS DISCHARGED 17 DAYS POST PROCEDURE. THE PATIENT WAS SEEN IN THE CLINIC FOR FOLLOW UP 11 DAYS LATER AND HAD NO THROAT OR NECK DISCOMFORT AND ALL SYMPTOMS HAD RESOLVED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831489 DV8 ESOPHAGEAL RETRACTOR DV8 RETRACTOR GAD MANUAL SURGICAL SCIENCES, LLC 14075150

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R