BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19878371 · Received July 31, 2024

    Report

    Report Number
    3008062894-2024-00043
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 12, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/21/2024 - WE WERE NOTIFIED OF A PATIENT WHO HAS HAD THE CAPSULE IN HER BODY FOR 2 WEEKS NOW, AND SAID THAT BASED ON HER LAST DOCTOR'S VISIT, IT IS STUCK. FRM-0089C - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN MORE INFORMATION AND THE SN.ALSO, A REPLACEMENT RETRIEVAL PAN WAS SENT TO THE PATIENT AS REQUESTED BY THEM. ON 7/10/2024 - WE WERE NOTIFIED THAT THE PATIENT'S PHYSICIAN REFERRED HER TO ANOTHER DOCTOR SINCE THEY WERE PLANNING TO HAVE A PROCEDURE DONE ON (B)(6) 2024. THIS IS THE DATE WHERE WE BECAME AWARE OF SERIOUS INJURY TO THE PATIENT. ON 7/23/2024 - WE WERE NOTIFIED THAT THE PATIENT WAS STILL AWAITING SURGERY ON 7/30/2024 - FRM-0089C HAS STILL NOT BEEN RECEIVED AND WE HAVEN'T GOTTEN ANY UPDATES ON THE SURGERY.

    Additional Manufacturer Narrative · 0

    6/21/2024 - WE WERE NOTIFIED OF A PATIENT WHO HAS HAD THE CAPSULE IN HER BODY FOR 2 WEEKS NOW, AND SAID THAT BASED ON HER LAST DOCTOR'S VISIT, IT IS STUCK. FRM-0089C - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN MORE INFORMATION AND THE SN. ALSO, A REPLACEMENT RETRIEVAL PAN WAS SENT TO THE PATIENT AS REQUESTED BY THEM. 7/10/2024 - WE WERE NOTIFIED THAT THE PATIENT'S PHYSICIAN REFERRED HER TO ANOTHER DOCTOR SINCE THEY WERE PLANNING TO HAVE A PROCEDURE DONE ON (B)(6) 2024. 7/23/2024 - WE WERE NOTIFIED THAT THE PATIENT WAS STILL AWAITING SURGERY, 7/30/2024 - FRM-0089C HAS STILL NOT BEEN RECEIVED AND WE HAVEN'T GOTTEN ANY UPDATES ON THE SURGERY. SUPPLEMENTAL INFORMATION. 9/4/2024 - WE RECEIVED THE COMPLETED FRM-0089C THAT INDICATED THE SN OF THE CAPSULE, AND ALSO THAT THE PATIENT HAD A DOUBLE BALLOON ENTEROSCOPY WITH CAPSULE REMOVAL. PATIENT DID NOT HAVE PRE-EXISTING CONDITIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2024 - WE WERE NOTIFIED OF A PATIENT WHO HAS HAD THE CAPSULE IN HER BODY FOR 2 WEEKS NOW, AND SAID THAT BASED ON HER LAST DOCTOR'S VISIT, IT IS STUCK. FRM-0089C - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN MORE INFORMATION AND THE SN. ALSO, A REPLACEMENT RETRIEVAL PAN WAS SENT TO THE PATIENT AS REQUESTED BY THEM. ON 7/10/2024 - WE WERE NOTIFIED THAT THE PATIENT'S PHYSICIAN REFERRED HER TO ANOTHER DOCTOR SINCE THEY WERE PLANNING TO HAVE A PROCEDURE DONE ON (B)(6) 2024. ON 7/23/2024 - WE WERE NOTIFIED THAT THE PATIENT WAS STILL AWAITING SURGERY, ON 7/30/2024 - FRM-0089C HAS STILL NOT BEEN RECEIVED AND WE HAVEN'T GOTTEN ANY UPDATES ON THE SURGERY.

    Description of Event or Problem · 0

    9/4/2024 - WE RECEIVED THE COMPLETED FRM-0089C THAT INDICATED THE SN OF THE CAPSULE, AND ALSO THAT THE PATIENT HAD A DOUBLE BALLOON ENTEROSCOPY WITH CAPSULE REMOVAL. PATIENT DID NOT HAVE PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913249 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-23-0191

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| O