BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPE 5.5MM

    MDR report key: 10951131 · Received December 5, 2020

    Report

    Report Number
    1124841-2020-00275
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    October 1, 2020
    Report Date
    January 21, 2021
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    GCJ
    UDI-DI
    00699753018952
    PMA / PMN Number
    K092789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6 (IDENTIFICATION OF EVALUATION CODES 886, 2199, 4582, 3001, 3331, 4114, 3224, 19). COMPONENT CODE: 866 - LENSES. HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE PROBLEM CODE: 3001 - OPTICAL PROBLEM. TYPE OF INVESTIGATION #1: 3331 - ANALYSIS OF PRODUCTION RECORDS TYPE OF INVESTIGATION #2: 4114 - DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 3224 - OPTICAL PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 19 - CAUSE TRACED TO USER. THE SAMPLE WAS NOT RETURNED SO A DIRECT INVESTIGATION COULD NOT BE PERFORMED. PAST PRODUCT COMPLAINTS WERE REVIEWED FOR SIMILAR ISSUES AND THE MOST LIKELY ROOT CAUSE IS 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.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, 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. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING THE ENDOSCOPE WAS BLURRED SO THEY HAD TO OPEN THE LEG OF THE PATIENT DURING HEPARINIZING. APPROXIMATELY A HALF HOUR DELAY. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415782 ENDOSCOPE 5.5MM LAPAROSCOPE, GENERAL GCJ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MCENDO550 648838 00699753018952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention