BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 18243750 · Received November 30, 2023

    Report

    Report Number
    9610877-2023-00273
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 9, 2023
    Report Date
    January 24, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333233007
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H6 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 CODE: 424 CAP. TYPE OF INVESTIGATION: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED. INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE. BELOW IS THE RESPONSE FROM THE HOSPITAL AFTER PERFORMING A GOOD FAITH EFFORT (GFE). WAS THE PROCEDURE FOR TREATMENT OR DIAGNOSTIC PURPOSES-TREATMENT WAS EITHER PRODUCT USED TO COMPLETE THE PROCEDURE? NO. DID A NURSE ATTACH THE CAP TO THE DISTAL PART OF THE ENDOSCOPE? IF SO, DID THEY HEAR THE CLICKING SOUND WHEN ATTACHING IT? YES, SHE ATTACHED AND HEARD THE CLICK. DID THE DUODENOSCOPE ELEVATOR BREAK AFTER BEING REMOVED FROM THE PATIENT? NO. CAN YOU CONFIRM THE ELEVATOR BROKE DURING TROUBLE SHOOTING/TESTING? ANOTHER ONE SAME LOT WAS TESTED TO TRY TO REPEAT THE ACTION OF THE FIRST ONE FALLING OFF. DID THE TROUBLESHOOTING TESTING INVOLVE REATTACHING THE DEC AND TRYING TO REMOVE IT FROM THE DUODENOSCOPE? NO. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MANUFACTURER MDR 9610877-2023-00272, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 021122 MANUFACTURER MDR, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    H6 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. TYPE OF INVESTIGATION: 3331 ANALYSIS OF PRODUCTION RECORDS, 4111. COMMUNICATION/INTERVIEWS, 4114 DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 3221 NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 4315 CAUSE NOT ESTABLISHED. EVALUATION SUMMARY: PENTAX MEDICAL HAS REQUESTED THE CUSTOMER TO RETURN THE COMPLAINT DUODENOSCOPE, BUT TO DATE THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ALTHOUGH THE DEVICE WAS NOT RETURNED, COMMUNICATIONS AND INTERVIEWS WERE CONDUCTED, AS WELL AS A REVIEW/ANALYSIS OF THE PRODUCTION RECORDS WAS PERFORMED. ADDITIONALLY, THE CUSTOMER STATED THAT THERE WAS NO KNOWN PROBLEM WITH THE DUODENOSCOPE. IF A STERILE DISTAL END CAP(DEC) IS NOT PROPERLY ATTACHED TO THE TIP OF THE DUODENOSCOPE, IT COULD RESULT IN THE DEC FALLING OFF IF IT IS SUBJECTED TO A LOAD OR FORCE. HOWEVER, THIS HAS NOT BEEN DETERMINED IN THIS CASE. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 12-SEP-2019 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 12-SEP-2019. BASED ON THE MANUFACTURE INVESTIGATION THE ROOT CAUSE WAS NOT ABLE TO BE ESTABLISHED. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. MANUFACTURER MDR 9610877-2023-00272, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 021122. MANUFACTURER MDR 9610877-2023-00273, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 09-NOV-2023 THAT OCCURRED DURING USE IN CANADA INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(6). REASSESSMENT OF THE EVENT BASED ON GOOD FAITH EFFORT(GFE) RESPONSE RECEIVED FROM THE USER VIA EMAIL ON (B)(6) 2023. THE CUSTOMER REPORTED THAT AFTER HEARING THE CLICK SOUND WHEN ATTACHING THE DEC TO THE DISTAL END OF THE DUODENSOSCOPE THE DEC HAD COME OFF IN THE PATIENT'S MOUTH DURING TREATMENT. ANOTHER DEC, ALSO LOT NUMBER 002122, WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. 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
    1400009 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other