BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 18882953 · Received March 11, 2024

    Report

    Report Number
    9610877-2024-00030
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 1, 2022
    Report Date
    May 20, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333232994
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: 4641 UNEXPECTED MEDICAL INTERVENTION; MEDICAL DEVICE PROBLEM CODE: 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT COMPONENT CODE: 424 CAP; TYPE OF INVESTIGATION: 4111 COMMUNICATION/INTERVIEWS; INVESTIGATION FINDINGS: 114 OPERATIONAL PROBLEM IDENTIFIED; INVESTIGATION CONCLUSIONS: 19 CAUSE TRACED TO USER. CORRECTION INFORMATION: B4: DATE OF THIS REPORT; H2:IF FOLLOW-UP, WHAT TYPE?; H3:DEVICE EVALUATED BY MANUFACTURE; H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. 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. IT WAS DETERMINED THAT THE DISTAL END CAP (DEC) WAS NOT PROPERLY ATTACHED BY THE USER, AND THAT THE DEC MOST LIKELY FELL OFF IN THE STOMACH DUE TO THE LOAD APPLIED TO THE TIP WHEN IT WAS INSERTED INTO THE PATIENT'S DUODENUM. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. MANUFACTURER MDR 9610877-2024-00030, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0011112 OR 0021122. MANUFACTURER MDR 9610877-2024-00031, 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: 4641 UNEXPECTED MEDICAL INTERVENTION MEDICAL DEVICE PROBLEM CODE: 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT 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 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. MANUFACTURER MDR 9610877-2024-00030, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0011112 OR 0021122 MANUFACTURER MDR 9610877-2024-00031, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER UNKNOWN.

    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 STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 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 22 MONTHS AGO (B)(6) 2022). 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. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 22 MONTH AGO (B)(6) 2022). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS (B)(6) 2022. 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
    1028138 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 Required Intervention