BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE 5.5MM

    MDR report key: 17237744 · Received June 30, 2023

    Report

    Report Number
    1124841-2023-00161
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Report Date
    August 4, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    GCJ
    UDI-DI
    00699753018952
    PMA / PMN Number
    K092789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE 11. COMPONENT CODE: 866- LENSES. HEALTH EFFECT ¿ IMPACT CODE: 4648- INSUFFICIENT INFORMATION. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 3001 - OPTICAL PROBLEM. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JUNE 30, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6 (ADVERSE EVENT PROBLEM 2199, 10, 3224, 3259, 19). HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCE OR IMPACT. TYPE OF INVESTIGATION: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. INVESTIGATION FINDINGS #1: 3224- OPTICAL PROBLEM IDENTIFIED. INVESTIGATION FINDINGS #2: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 19 - CAUSE TRACED TO USER. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT AND A VISUAL OBSERVATION OF THE INTERNAL COMPONENTS USING A MONOCULAR WAS CONDUCTED. IT WAS DISCOVERED THAT THERE WAS A CRACK ON ONE OF THE INTERNAL LENSES WHICH RESULTED IN A BLURRY VISUAL FIELD. IMPROPER HANDLING CAUSED THE INTERNAL LENS TO BREAK. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ENDOSCOPE WAS BLURRY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, AND IF THE SURGERY WAS COMPLETED SUCCESSFULLY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS CHANGED OUT WITH NO HARM AND NO BLOOD LOSS.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED INDICATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. *NO CONSEQUENCE OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562282 ENDOSCOPE 5.5MM LAPAROSCOPE, GENERAL GCJ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MCENDO550 UNKNOWN 00699753018952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown