BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 18879670 · Received March 11, 2024

    Report

    Report Number
    2518897-2024-00015
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 1, 2023
    Report Date
    May 20, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333232994
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B4: DATE OF THIS REPORT; B5. REFER TO H11; F7: FOLLOW UP #01; F11: UPDATED DATES; F13: UPDATED DATES. ADDITIONAL INFORMATION: D4: UNIQUE IDENTIFIER (UDI) CORRECTED; H11: EVALUATION SUMMARY; EVALUATION SUMMARY: PENTAX MEDICAL AMERICA PERFORMED A GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND PROVIDED AN EMAIL, BUT HAD NOT RECEIVED A RESPONSE. THE INVESTIGATION DETERMINED THAT THE DISTAL END CAP (DEC) WAS NOT PROPERLY ATTACHED BY THE USER AND THE ENDOSCOPE MOST LIKELY CAME INTO CONTACT WITH THE TEETH OR MOUTHPIECE WHEN IT WAS TAKEN OUT OF THE MOUTH, CAUSING THE DEC TO FALL INTO THE MOUTH DUE TO THE IMPACT. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. IMPORTER MDR 2518897-2024-00015, DEC DISTAL CAP MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. IMPORTER MDR 2518897-2024-00016, DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE HEALTH EFFECT IMPACT CODE: 2199 NO HEALTH CONSEQUENCES OR IMPACT MEDICAL DEVICE PROBLEM CODE: 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT COMPONENT CODE: 424 CAP ______ CUSTOMER DID NOT RECORD ANY OF THE LOT NUMBERS IN ANY OF THE PATIENT CHARTS WHEN THIS OCCURRED. AT THIS TIME THEY DO NOT HAVE TRACEABILITY ON THE DISTAL CAPS ON WHICH LOT NUMBER WAS USED. PER THE ACCOUNT, THEY ONLY HAVE TWO LOT NUMBERS OF STERILE DISTAL END CAP MODEL #: OE-A63 ON SITE. LOT #: 0011112 & 0021122. THEREFORE, THE D4 LOT NUMBER IS LISTED AS #: 0011112 AND 0021122, TWO LOT NUMBERS. PENTAX MEDICAL AMERICA PERFORMED A GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND PROVIDED AN EMAIL, BUT HAS NOT RECEIVED A RESPONSE AT THIS TIME. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. IMPORTER MDR 2518897-2024-00015, DEC DISTAL CAP MODEL OE-A63, LOT NUMBER 0011112 OR 0021122 IMPORTER MDR 2518897-2024-00016, DUODENOSCOPE MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER.

    Description of Event or Problem · 0

    REFER TO H11.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THE OE-A63 STERILE DISTAL END CAP CAME OFF INSIDE OF THE PATIENT'S MOUTH, HOWEVER, THEY WERE ABLE TO RETRIEVE THE STERILE DISTAL END CAP. THIS WAS NOT REPORTED PREVIOUSLY BY THE USER FACILITY'S ENDOSCOPY TECHNICIAN SUPERVISOR. THE EXACT DATE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 2 MONTHS AGO (DECEMBER 2023). THE CUSTOMER ALSO DID NOT RECORD ANY OF THE LOT NUMBERS IN ANY OF THE PATIENT CHARTS WHEN THIS OCCURRED. AT THIS TIME THEY DO NOT HAVE TRACEABILITY ON THE DECS LOT NUMBERS USED. PER THE ACCOUNT, THEY ONLY HAVE TWO LOT NUMBERS OF STERILE DISTAL END CAP MODEL #: OE-A63 ON SITE. LOT #: 0011112 & 0021122. ADDITIONALLY THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 2 MONTH AGO (DECEMBER 2023). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS 01-JAN-2023. 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
    2454637 PENTAX STERILE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011112 OR 0021122 04961333232994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other