BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDEO DUODENOSCOPE

    MDR report key: 20447744 · Received October 14, 2024

    Report

    Report Number
    9610877-2024-00145
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    January 1, 2024
    Report Date
    December 19, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6:CONTINUED: HEALTH EFFECT - CLINICAL CODE : 1699 AIRWAY OBSTRUCTION, 4599 UPPER RESPIRATORY TRACT INJURY HEALTH EFFECT - IMPACT CODE : 4608 INTENSIVE CARE, 4641 UNEXPECTED MEDICAL INTERVENTION MEDICAL DEVICE PROBLEM CODE : 3190 INSUFFICIENT INFORMATION COMPONENT CODE : 4776 INSUFFICIENT INFORMATION TYPE OF INVESTIGATION : 10 TESTING OF ACTUAL/SUSPECTED DEVICE INVESTIGATION FINDINGS : 3233 RESULTS PENDING COMPLETION OF INVESTIGATION INVESTIGATION CONCLUSIONS: 11 CONCLUSIONS NOT YET AVAILABLE. PENTAX MEDICAL PAI PERFORMED FOUR GOOD FAITH EFFORTS AND OBTAINED THE FOLLOWING INFORMATION: THERE WERE THE SAME REPORTS FOR TWO ENDOSCOPES, BUT THERE WAS ONLY ONE PATIENT. TWO ENDOSCOPES WERE USED IN ONE CASE, BUT IT IS UNCLEAR TO WHAT EXTENT EACH ENDOSCOPE WAS INVOLVED IN THE HARM TO THE PATIENT. ADDITIONAL INFORMATION PENTAX MEDICAL INSPECTED THE ENDOSCOPE RETURNED FOR REPAIR AND OBTAINED THE FOLLOWING RESULTS. SERIAL NUMBER: (B)(6). DEFORMED: AIR/WATER SOCKET, CUSTOMER COMPLAINT DUPLICATE: CUSTOMER COMPLAINT FINDINGS, DRY LEAK TEST PASS: SCOPE LEAK TEST FUNCTION, DST ELECTRICAL SAFETY TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, PLCT ELECTRICAL SAFETY TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, RESISTANCE ELECTRICAL TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, WET LEAK TEST PASS: SCOPE LEAK TEST FUNCTION SERIAL NUMBER: (B)(6). CRACKED: LCB DISTAL COVER GLASS, DEFORMED: AIR/WATER SOCKET, RESISTANCE: OPERATION CHANNEL (PRIMARY), KINK: SUCTION CHANNEL, CUSTOMER COMPLAINT DUPLICATE: CUSTOMER COMPLAINT FINDINGS, DRY LEAK TEST FAIL: SCOPE LEAK TEST FUNCTION, DST ELECTRICAL SAFETY TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, PLCT ELECTRICAL SAFETY TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, RESISTANCE ELECTRICAL TEST PASS: SCOPE ELECTRICAL TEST FUNCTION, WET LEAK TEST FAIL: SCOPE LEAK TEST FUNCTION. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 9610877-2024-00144_ED34-I10T2_(B)(6)_TRACHEAL EDEMA AND VOCAL CORD DAMAGE. _ED34-I10T2_(B)(6)_TRACHEAL EDEMA AND VOCAL CORD DAMAGE.

    Additional Manufacturer Narrative · 0

    H6:CONTINUED: HEALTH EFFECT - CLINICAL CODE : 1699 AIRWAY OBSTRUCTION, 4599 UPPER RESPIRATORY TRACT INJURY HEALTH EFFECT - IMPACT CODE : 4608 INTENSIVE CARE, 4641 UNEXPECTED MEDICAL INTERVENTION MEDICAL DEVICE PROBLEM CODE : 3190 INSUFFICIENT INFORMATION COMPONENT CODE : 4776 INSUFFICIENT INFORMATION TYPE OF INVESTIGATION : 10 TESTING OF ACTUAL/SUSPECTED DEVICE INVESTIGATION FINDINGS : 114 OPERATIONAL PROBLEM IDENTIFIED INVESTIGATION CONCLUSIONS : 19 CAUSE TRACED TO USER CORRECTION INFORMATION B4: DATE OF THIS REPORT G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE H6: ADVERSE EVENT PROBLEM ADDITIONAL INFORMATION D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # H4: DEVICE MANUFACTURE DATE EVALUATION SUMMARY THE INVESTIGATION DETERMINED THAT POTENTIAL ROOT CAUSES OF THIS FAILURE INCLUDED THE PHYSICIAN'S INSUFFICIENT UNDERSTANDING AND VISUALIZATION OF THE ANATOMICAL STRUCTURE, POOR INSERTION TECHNIQUE, INEXPERIENCE WITH INTUBATED PATIENTS, HASTE IN THE EMERGENCY SITUATION, AND INSUFFICIENT TRAINING AND EXPERIENCE. IT WAS DETERMINED THAT ONE OR MORE OF THESE FACTORS COMBINED TO CAUSE THE MISINSERTION OF THE ENDOSCOPE, BUT WAS UNABLE TO IDENTIFY THE SPECIFIC CAUSE. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 17-MAR-2020 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 1-APR-2020. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. 9610877-2024-00144_ED34-I10T2_(B)(6)_TRACHEAL EDEMA AND VOCAL CORD DAMAGE 9610877-2024-00145_ED34-I10T2_(B)(6)_TRACHEAL EDEMA AND VOCAL CORD DAMAGE.

    Description of Event or Problem · 0

    B3:NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. PENTAX MEDICAL INITIALLY BECAME AWARE OF AN EVENT ON 27-SEP-2024 WHICH WAS ORIGINALLY CALLED IN TO CUSTOMER SERVICE AS A MAINTENANCE REQUEST OR AIR/WATER PORT LOOSE - KEEPS COMING OFF INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34- I10T2, SERIAL NUMBER (B)(6). AT THE TIME, THE COMPLAINANT FROM THIS USER FACILITY STATED THAT THERE WAS NO HARM TO ANY PATIENT. HOWEVER, THE NEXT DAY A FOLOW UP EMAIL WAS SUBMITTED BY THE COMPLAINANT STATING THAT THERE WAS HARM TO A PATIENT. THE PATENT HAD TO REMAIN INTUBATED AND BE FLOWN TO (B)(6) HOSPITAL. THEY HAD TRACHEAL EDEMA AND VOCAL CORD DAMAGE. THE DUODENOSCOPE WAS INSERTED INTO THE TRACHEA OF INTUBATED PATIENT. INFORMATION FOR A SECOND PENTAX MEDICAL VIDEO DUODENOSCOPE WAS PROVIDED DURING THE FOLOW UP EMAIL. MODEL ED34-I10T2, SERIAL NUMBER (B)(6). THE FOLLOWING STERILE DISTAL END CAP(DEC) INFORMATION WAS ALSO PROVIDED ALTHOUGH NO ALLEGATION WAS MADE AGAINST THE DEVICE: MODEL, OE-A63, LOT NUMBER 0021102. (EXPIRATION DATE 9/30/2024). ALTHOUGH THE COMPLAINT MENTIONS A SECOND DUODENOSCOPE THAT WAS INSERTED INTO THE TRACHEA OF INTUBATED PATIENT, BUT AN EXACT RELATIONSHIP TO THE ADVERSE EVENT HAS NOT YET BEEN PROVIDED AS WE ARE AWAITING THE GOOD FAITH EFFORT RESPONSE AS OF THE TIME OF ASSESSMENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32519 VIDEO DUODENOSCOPE VIDEO DUODENO SCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R