BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAIII BRONCHOVIDEOSCOPE

    MDR report key: 11861482 · Received May 21, 2021

    Report

    Report Number
    8010047-2021-06574
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 23, 2021
    Report Date
    August 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS FRANCE (OFR) FOR EVALUATION. FROM THE DEVICE INSPECTION RESULT PROVIDED BY OFR, OMSC CONFIRMED THAT THE DISTAL END WAS DEFORMED AND THERE WAS EVIDENCE OF IMPACT UP TO THE PERFORATED PART OF THE BENDING SECTION RUBBER. FROM THE INFORMATION PROVIDED BY THE USER, OMSC CONFIRMED THAT THE USER REPLACED THE ENDOTRACHEAL TUBE FROM AN INNER DIAMETER OF 7.0 MM TO AN INNER DIAMETER OF 7.5 MM, WHICH ELIMINATED THE STICKING OF THE ENDOTRACHEAL TUBE AND COMPLETED THE PROCEDURE. THEREFORE, IT IS POSSIBLE THAT THE DEVICE HAS STUCK IN THE ENDOTRACHEAL TUBE TWICE WITHOUT COMPLETELY PENETRATING THE ENDOTRACHEAL TUBE DUE TO THE USER'S MISSELECTION OF THE ENDOTRACHEAL TUBE. IT MAY ALSO HAVE BEEN CAUSED BY THE BENDING SECTION RUBBER NOT MOVING SMOOTHLY INSIDE THE ENDOTRACHEAL TUBE, BASED ON THE PAST SIMILAR CASES. IN ADDITION, OMSC DETERMINED THAT THE REPORTED EVENT COULD BE PREVENTED BECAUSE THE INSTRUCTION MANUAL PROVIDES PRECAUTIONS WHEN USING AN ENDOTRACHEAL TUBE WITH THE ENDOSCOPE. OMSC CONFIRMED THAT AFTER THE DEVICE STUCK IN THE ENDOTRACHEAL TUBE WITH AN INNER DIAMETER OF 7.0 MM, THE USER WITHDREW THE DEVICE FROM THE ENDOTRACHEAL TUBE AND REPLACED IT WITH AN ENDOTRACHEAL TUBE WITH AN INNER DIAMETER OF 7.5 MM TO COMPLETE THE PROCEDURE. THEREFORE, OMSC CONCLUDED THAT THE BENDING SECTION RUBBER WAS STRIPPED FROM THE BENDING SECTION DUE TO EXCESSIVE FORCE APPLIED TO THE DEVICE WHEN THE CLOGGED DEVICE WAS WITHDREW FROM THE ENDOTRACHEAL TUBE. BASED ON THE PAST SIMILAR CASES, IT IS POSSIBLE THAT THE LIGHT GUIDE LENS WAS MISSING DUE TO EXTERNAL STRESS APPLIED TO THE DISTAL END OF THE DEVICE DUE TO HANDLING OUTSIDE THE PROCEDURE SUCH AS BUMPING OR DROPPING. OMSC DETERMINED THAT THE MISSING OF THE LIGHT GUIDE LENS COULD BE PREVENTED BECAUSE THE INSTRUCTION MANUAL PROVIDES WARNINGS AND CAUTIONS REGARDING THE HANDLING OF THE DISTAL END OF THE ENDOSCOPE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THERE WAS A LEAKAGE AT THE BENDING SECTION RUBBER DUE TO PERFORATION. DUE TO THE RIPPING OF THE BENDING SECTION RUBBER, THE LEAK TEST COULD NOT BE COMPLETED AND THE SUCTION CAPACITY INSPECTION COULD NOT BE PERFORMED. ONE OF THE TWO LIGHT GUIDE ROD LENSES HAD A DEEP SCRATCH AND THE OTHER WAS MISSING AND BROKEN. THE BIOPSY CHANNEL WAS DEFORMED AT THE POSITION OF THE BENDING SECTION ZONE. THE VENTING CONNECTOR WAS ROTATING A QUARTER TURN. THIS PRODUCT WAS SOLD IN (B)(6) 2019 AND HAS NEVER BEEN REPAIRED. THE DISTAL END DEFECT MAY HAVE BEEN CAUSED BY THE FORCE APPLIED DURING THE WITHDRAWAL OF THE ENDOSCOPE DUE TO THE SMALL DIAMETER OF THE ENDOTRACHEAL TUBE. IN ADDITION, DAMAGE TO THE LIGHT GUIDE LENS MAY HAVE BEEN CAUSED DURING REPROCESSING OR PRE-PROCEDURE STORAGE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE BRONCHIAL FIBROSCOPY UNDER GENERAL ANESTHESIA FOR BRONCHOALVEOLAR LAVAGE, WHEN THE DOCTOR WITHDREW THE ENDOSCOPE FROM THE PATIENT, THE DEVICE GOT STUCK IN THE ENDOTRACHEAL TUBE TWICE WITHOUT COMPLETELY PENETRATING THE ENDOTRACHEAL TUBE. AND THE USER CHANGED FROM THE ENDOTRACHEAL TUBE WITH A DIAMETER OF 7.0 MM TO 7.5 MM. AFTER THAT, THE INSPECTION WAS DONE WITHOUT ANY PROBLEMS, AND THE PRE-TREATMENT OF THE PATIENT PROCEEDED NORMALLY. THE PROCEDURE USUALLY TAKES 5 MINUTES, BUT WAS EXTENDED BY 5 MINUTES DUE TO THE OCCURRENCE OF THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. IN ADDITION, THE USER REPORTED THAT DOCTOR FOUND A MISSING GLASS IN THE CENTER OF THE LIGHT GUIDE ROD LENS AND A PERFORATION IN THE DISTAL SHEATH DURING THE INSPECTION. THE PIECE OF GLASS WAS NOT RECOVERED FROM THE PATIENT AND IT WAS UNCLEAR WHETHER IT HAD FALLEN INSIDE OR OUTSIDE THE ENDOTRACHEAL TUBE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT AT THIS TIME. OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE BENDING SECTION RUBBER WAS RIPPED OUT FROM THE BENDING SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759440 EVIS EXERAIII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR