BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIROCAM CAPSULE ENDOSCOPE SYSTEM

    MDR report key: 18863241 · Received March 8, 2024

    Report

    Report Number
    3007244127-2023-12001
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    November 10, 2023
    Report Date
    December 20, 2023
    Manufacturer
    INTROMEIDC CO., LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K180732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT PRODUCT THAT OCCURRED IN AUSTRIA WAS RETURNED TO THE MANUFACTURER ON (B)(6). THE MANUFACTURER HAS INCURRED DELAYS IN THE PROCESS OF CONDUCTING TESTS AND VERIFICATIONS TO IDENTIFY THE CAUSE OF THE PRODUCT. ADDITIONALLY, SUBMISSION DEADLINES HAVE BEEN DELAYED DUE TO ERRORS IN SUBMITTER AND THE VERIFICATION PROCESS OF ESG ACCOUNTS. AND ON (B)(6) 2024, WE CONFIRMED THAT THERE WAS AN ERROR IN THE FILE UPLOADED TO ESG. THE PATIENT HAD NO INJURIES, AND A CAPSULE ENDOSCOPY WAS PERFORMED AGAIN. THE MANUFACTURER ACKNOWLEDGED RECEIPT OF THE REQUEST FROM THE AUSTRIAN AGENCY ON (B)(6). SUBSEQUENTLY, THE MANUFACTURER INITIATED A FORMAL REQUEST FOR THE RETURN OF THE PRODUCT IN QUESTION, AND THE SAID PRODUCT WAS SUCCESSFULLY RETRIEVED BY THE MANUFACTURER ON (B)(6). THE RECEIVER MANIFESTED NO OBSERVABLE ISSUES IN TERMS OF ITS APPEARANCE, AND NO PROBLEMS WERE IDENTIFIED DURING THE INVESTIGATIVE PROCESS SUBSEQUENT TO DISASSEMBLY. THE DATA CABLE, POSSESSING A STRUCTURE AKIN TO A STANDARD ECG CABLE, UNDERWENT LOCAL DISASSEMBLY AND SUBSEQUENT RETRIEVAL. UPON THOROUGH INVESTIGATION OF ITS DISASSEMBLED STATE, IT WAS DISCERNED THAT THE CABLE WIRE HAD BEEN SEVERED AS A RESULT OF HUMAN FORCE. DESPITE THE PATIENT'S ASSUMPTION OF A COMBUSTION EVENT, PROMPTED BY THE PRODUCT'S ELEVATION IN TEMPERATURE, NO TRACES INDICATIVE OF COMBUSTION WERE DISCOVERED. NOTABLY, THE DATA CABLE COMPRISES A TOTAL OF NINE LINES, ENCOMPASSING EIGHT DATA LINES AND ONE GND LINE, WITH NO LINES RELATED TO POWER EXISTING. THE ELEVATION IN TEMPERATURE OBSERVED IN THE RECEIVER IS ATTRIBUTABLE TO THE HEAT GENERATED DURING THE NORMAL OPERATION OF THE PRODUCT. FURTHERMORE, IT HAS BEEN SUBSTANTIATED THAT THE TEMPERATURE AT ITS ZENITH PEAKED AT APPROXIMATELY 35 CC, SIGNIFYING THE ABSENCE OF ANY DISCERNIBLE ISSUES. IN CONCLUSION, THE PRODUCT EXHIBITED NO ISSUES OR ABNORMALITIES THROUGHOUT THE INVESTIGATION.

    Description of Event or Problem · 0

    ACCORDING TO ISLAMOVIC, AT APPROXIMATELY 2 PM, SHE OBSERVED AN INCREASE IN TEMPERATURE IN THE DEVICE, AND SHORTLY THEREAFTER, THE CABLE ALSO EXPERIENCED ELEVATED HEAT LEVELS, RESULTING IN AN AUTOMATIC DISCONNECTION. PAT DID NOT EXHIBIT ANY VISIBLE INJURIES. SUBSEQUENTLY, THE CAPSULE ENDOSCOPY PROCEDURE WAS REPEATED ON THE FOLLOWING MONDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171976 MIROCAM CAPSULE ENDOSCOPE SYSTEM INGESTIBLE TELEMETRIC GASTROINTESTINAL CAPSULE IMAGING SYSTEM NEZ INTROMEIDC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female MR2000-D