BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DV8 ESOPHAGEAL RETRACTOR

    MDR report key: 7054652 · Received November 22, 2017

    Report

    Report Number
    3011596926-2017-00004
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    July 7, 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

    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 PAIN. UNINTERRUPTED ELIQUIS WAS GIVEN. THE DV8 DEVICE WAS EMPLOYED TO LATERALLY DISPLACE THE ESOPHAGUS; HOWEVER, ESOPHAGEAL INTUBATION WAS REPORTEDLY DIFFICULT. POST PROCEDURE, THE PATIENT EXPERIENCED PAIN IN THE OROPHARYNX AS WELL AS DYSPNEA. THE HOSPITAL EAR NOSE AND THROAT SERVICE WAS CONSULTED, AND A LARYNGOSCOPY WAS PERFORMED. MUCOSAL INJURY WAS NOTED IN THE VALLECULA AND ARYTENOID, THOUGHT LIKELY SECONDARY TO TRAUMA. NO OTHER AIRWAY INJURY WAS NOTED. THE PATIENTS VOICE WAS STABLE AND THERE WAS NO EVIDENCE OF A VOCAL CORD INJURY. THE PATIENT RECEIVED A DOSE OF INTRAVENOUS TYLENOL AND THE DISCOMFORT IMPROVED SEVERAL HOURS AFTER EXTUBATION. THE FOLLOWING DAY, THE PATIENT HAD A CHEST X-RAY, WHICH REVEALED NO EVIDENCE OF A PNEUMOTHORAX. A CONTRAST ESOPHAGRAM WAS ALSO COMPLETED, WHICH REVEALED NO EVIDENCE OF ESOPHAGEAL/PHARYNGEAL PERFORATION. THE PATIENT WAS FEELING WELL THE FOLLOWING DAY WITH MINIMAL THROAT AND NECK DISCOMFORT AND WAS DISCHARGED. THE PATIENT WAS SEEN A MONTH LATER AND HAD NO THROAT OR NECK DISCOMFORT. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831490 DV8 ESOPHAGEAL RETRACTOR DV8 RETRACTOR GAD MANUAL SURGICAL SCIENCES, LLC 14075150

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention