BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX MEDICAL

    MDR report key: 21847481 · Received April 16, 2025

    Report

    Report Number
    9610877-2025-00031
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 9, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333222209
    PMA / PMN Number
    K183516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: HEALTH EFFECT - CLINICAL CODE: 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE. HEALTH EFFECT - IMPACT CODE: 4603 DELAY TO DIAGNOSIS, 4641 UNEXPECTED MEDICAL INTERVENTION. MEDICAL DEVICE PROBLEM CODE: 4008 MATERIAL SPLIT, CUT OR TORN. COMPONENT CODE: 419 BALLOON. 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. ADDITIONAL INFORMATION: THIS EVENT WAS REPORTED TO THE FRENCH COMPETENT AUTHORITY (ANSM) UNDER REPORT NUMBER (B)(4). THE MATERIOVIGILANCE NUMBER ASSIGNED TO THIS EVENT BY ANSM IS (B)(4). INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 9610877-2025-00030_OE-A61_(B)(6) BALLOON RUPTURED AND FELL INTO BODY. OE-A61_(B)(6)_BALLOON RUPTURED AND FELL INTO BODY.

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: HEALTH EFFECT - CLINICAL CODE : 1762 CARDIAC ARREST, 4461 RESPIRATORY ARREST. HEALTH EFFECT - IMPACT CODE : 1802 DEATH, 4635 UNEXPECTED DETERIORATION. MEDICAL DEVICE PROBLEM CODE : 2993 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COMPONENT CODE : 4776 INSUFFICIENT INFORMATION. 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. 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 H11: EVALUATION SUMMARY. EVALUATION SUMMARY EVENT THAT OCCURRED IS THE PATIENT'S HEALTH DETERIORATES. A DHR REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE PRODUCT AND NO DEVIATION OR NON-CONFORMANCE WAS NOTED. BASED ON THE INVESTIGATION AND GFE, THE GASTROINTESTINAL BLEEDING HAD OCCURRED BEFORE THE ENDOSCOPE WAS INSERTED, AND IT WAS DETERMINED THAT IT WAS NOT DUE TO EQUIPMENT FAILURE. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE/HAZARD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT PENTAX MEDICAL MIYAGI ON 05-JUL-2024 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 16-JUL-2024. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE/HAZARD. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    WE WOULD LIKE TO CORRECT THE INFORMATION SUBMITTED IN FOLLOW-UP REPORT 1. FOLLOW-UP REPORT 1 WAS SUBMITTED IN ERROR AND DOES NOT ACCURATELY REFLECT THE FACTS OF THE EVENT. THE ACCURATE AND CORRECTED INFORMATION IS NOW PROVIDED IN THIS FOLLOW-UP REPORT 2. WE APOLOGIZE FOR ANY CONFUSION THIS MAY HAVE CAUSED. H6 CONTINUED: HEALTH EFFECT: CLINICAL CODE: 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE. HEALTH EFFECT: IMPACT CODE: 4603 DELAY TO DIAGNOSIS, 4641 UNEXPECTED MEDICAL INTERVENTION. MEDICAL DEVICE PROBLEM CODE: 4008 MATERIAL SPLIT, CUT OR TORN. COMPONENT CODE: 419 BALLOON. TYPE OF INVESTIGATION: 4110 TREND ANALYSIS, 3331 ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS: 193 STORAGE PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 4307 CAUSE TRACED TO COMPONENT FAILURE. CORRECTION INFORMATION: B4: DATE OF THIS REPORT. G6: FOLLOW-UP #: 2. H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY: EVENT THAT OCCURRED: A DEFECTIVE BALLOON WAS IDENTIFIED. SUMMARY OF EVENTS THAT OCCURRED: BASED ON THE INVESTIGATION, THE DEFECTIVE BALLOONS WERE NOT RETAINED BY THE FACILITY, AND THE EXACT NUMBER OF AFFECTED UNITS COULD NOT BE CONFIRMED. A POTENTIAL ROOT CAUSE OF THIS ISSUE IS IMPROPER STORAGE CONDITIONS, WHICH MAY HAVE CAUSED THE BALLOONS TO LOSE ELASTICITY AND DEVELOP CRACKS. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE/HAZARD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE REVIEW CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED UNDER NORMAL CONDITIONS ON 28-JUN-2024, 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 06-AUG-2024. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT, AND PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    ON 01-APR-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A MODEL: OE-A61, LOT NUMBER: 1011084 BALLOON WITHIN FRANCE IN THE EMEA REGION. DURING A PROCEDURE USING AN ULTRASOUND BRONCHOSCOPE, THE BALLOON AT THE DISTAL END RUPTURED. SINCE THE RUPTURED BALLOON WAS VISIBLE, IT WAS IMMEDIATELY REMOVED USING THE ENDOSCOPE. THIS RESPONSE EXTENDED THE PROCEDURE TIME AND THE PATIENT'S ANESTHESIA TIME. THE FACILITY DISCONTINUED THE USE OF BALLOONS FROM THE SAME LOT AND REPORTED THE EVENT TO PENTAX MEDICAL AND ANSM. THERE WAS NO REPORT OF PATIENT HARM. 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
    106607 PENTAX MEDICAL BALLOON EOQ HOYA CORPORATION PENTAX TOKYO OFFICE OE-A61 1011084 04961333222209

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention