BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19697784 · Received July 8, 2024

    Report

    Report Number
    3008062894-2024-00031
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    February 25, 2023
    Report Date
    July 8, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 03/15/2023 - WE WERE INFORMED ABOUT A PATIENT WHO DIED WHILE USING CAPSOCAM PLUS ON (B)(6) 2023. ACCORDING TO THE DOCTOR IN ATTENDANCE, THE DIRECT CAUSE OF DEATH WAS SUFFOCATION DUE TO BLEEDING FROM THE NOSE BLOCKING THE AIRWAY. FRM-0089 WITH A LIST OF QUESTIONS WAS SENT OUT TO THE DISTRIBUTOR TO OBTAIN MORE INFORMATION ON THE PATIENT AND THE CAUSE OF THE DEATH. FRM-0089 WAS RECEIVED INDICATING THE ONLY REASON THE HOSPITAL REACHED OUT TO THE DISTRIBUTOR WAS TO SEEK ADVICE ON THE PATIENT BODY THAT WAS GOING TO THE CREMATED WITH THE CAPSULE BUT THAT THE CAPSULE WAS NOT THE CAUSE OF THE PATIENT'S DEATH. ON 6/12/2024 WE RECEIVED AN EMAIL FROM THE PHYSICIAN, (B)(6) MD, INDICATING THAT THE PATIENT HAD UNDERGONE REPEATED OTOLARYNGOLOGICAL HEMOSTASIS FOR NASAL BLEEDING AFTER MAXILLARY SINUS CANCER SURGERY. THE DAY AFTER HAVING A CAPSULE ENDOSCOPY USING CAPSOCAM TO EXCLUDE SMALL INTESTINAL BLEEDING, THE PATIENT WAS FOUND TO BE IN CARDIAC ARREST. THERE WAS A LARGE AMOUNT OF TISSUE PAPER WITH BLOOD AROUND THE MOUTH AND BLOOD WAS ASPIRATED FROM THE AIRWAY. FROM THE COURSE OF THE CASE, IT IS THOUGHT THAT THE PATIENT SUFFOCATED DUE TO NASAL HEMORRHAGE DRIPPING INTO THE AIRWAY, AND THERE IS NO CAUSAL RELATIONSHIP BETWEEN THIS DEATH AND THE CAPSOCAM.

    Description of Event or Problem · 0

    ON 03/15/2023 - WE WERE INFORMED ABOUT A PATIENT WHO DIED WHILE USING CAPSOCAM PLUS ON (B)(6) 2023. ACCORDING TO THE DOCTOR IN ATTENDANCE, THE DIRECT CAUSE OF DEATH WAS SUFFOCATION DUE TO BLEEDING FROM THE NOSE BLOCKING THE AIRWAY. FRM-0089 WITH A LIST OF QUESTIONS WAS SENT OUT TO THE DISTRIBUTOR TO OBTAIN MORE INFORMATION ON THE PATIENT AND THE CAUSE OF THE DEATH. FRM-0089 WAS RECEIVED INDICATING THE ONLY REASON THE HOSPITAL REACHED OUT TO THE DISTRIBUTOR WAS TO SEEK ADVICE ON THE PATIENT BODY THAT WAS GOING TO THE CREMATED WITH THE CAPSULE BUT THAT THE CAPSULE WAS NOT THE CAUSE OF THE PATIENT'S DEATH. ON 6/12/2024 WE RECEIVED AN EMAIL FROM THE PHYSICIAN, (B)(6) MD, INDICATING THAT THE PATIENT HAD UNDERGONE REPEATED OTOLARYNGOLOGICAL HEMOSTASIS FOR NASAL BLEEDING AFTER MAXILLARY SINUS CANCER SURGERY. THE DAY AFTER HAVING A CAPSULE ENDOSCOPY USING CAPSOCAM TO EXCLUDE SMALL INTESTINAL BLEEDING, THE PATIENT WAS FOUND TO BE IN CARDIAC ARREST. THERE WAS A LARGE AMOUNT OF TISSUE PAPER WITH BLOOD AROUND THE MOUTH AND BLOOD WAS ASPIRATED FROM THE AIRWAY. FROM THE COURSE OF THE CASE, IT IS THOUGHT THAT THE PATIENT SUFFOCATED DUE TO NASAL HEMORRHAGE DRIPPING INTO THE AIRWAY, AND THERE IS NO CAUSAL RELATIONSHIP BETWEEN THIS DEATH AND THE CAPSOCAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391613 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death