BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23775588 · Received December 11, 2025

    Report

    Report Number
    3008146331-2025-00008
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    September 8, 2025
    Report Date
    February 13, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS INTENDED TO CORRECT THE CODING TERMS THAT WERE EITHER INCORRECTLY ENTERED OR OMITTED IN THE PREVIOUS REPORT. BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT AS A TRANSPYLORIC STENT. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE DISTRIBUTOR ALSO SUBMITTED A REPORT (REFERENCE NO.:2429304-2025-00255). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHAGEAL STENT AS A TRANSPYLORIC STENT. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE. NO FURTHER INFORMATION IS EXPECTED. THE INITIAL MDR SUBMISSION WAS DELAYED BECAUSE M.I.TECH WAS NOT AWARE THAT DISTRIBUTORS HAD INDEPENDENTLY SUBMITTED MDRS, AS SEVERAL NOTIFICATIONS WERE SENT TO AN INACTIVE EMAIL ADDRESS AND NO INTERNAL PROCESS YET EXISTED TO ROUTINELY VERIFY DISTRIBUTOR-SUBMITTED REPORTS. THIS GAP HAS NOW BEEN ADDRESSED THROUGH OLYMPUS STAFF RETRAINING, INITIATION OF A CAPA, AND M.I.TECH'S IMPLEMENTATION OF A REGULAR REVIEW PROCESS TO ENSURE TIMELY IDENTIFICATION OF MDR-REPORTABLE EVENTS.

    Description of Event or Problem · 0

    PLEASE REFER TO CUSTOMER'S RESPONSE BELOW: WHAT IS THE DATE OF THE EVENT? THE STENT WAS ORIGINALLY PLACED ON (B)(6). ON 9/8 THE PATIENT WENT TO THE ER WITH ABDOMINAL PAIN. WHAT WAS THE MODEL OF THE STENT ITSELF? ECBA-20-15-230, LOT #24101229 WAS THERE A DEATH RELATED TO THIS ISSUE? NO, NOT AT THIS TIME. PATIENT IS STABLE. WAS THERE AN INFECTION OR SUSPECTED INFECTION RELATED TO THIS EVENT? NO, NOT AT THIS TIME. PATIENT IS STABLE. WAS THERE A POSITIVE CULTURE TEST FINDING RELATED TO ANY DEVICES RELATED TO THIS ISSUE? N/A WHERE WAS THE ISSUE FIRST DISCOVERED? (PROCEDURE, PREPARATION FOR USE, REPROCESSING, TESTING AND MAINTENANCE, RECEIPT AND INSPECTION, INSTALLATION) ?: ON (B)(6) S/P ABD PAIN WHEN PT WENT TO ER. IF THE ISSUE OCCURRED DURING THE PROCEDURE: 1. WHAT WAS THE NAME OF THE PROCEDURE? INITIAL PROCEDURE WHEN STENT WAS PLACED ON (B)(6) - EGD FOR H/O GASTRIC ULCER PERF S/P SUTURING W TRANSPYLORIC STENT PLACEMENT SCHEDULED FOR REMOVAL AFTER 4 WEEKS. 2. WAS THE PROCEDURE THERAPEUTIC OR DIAGNOSTIC? THERAPEUTIC 3. AT WHAT POINT OF THE PROCEDURE DID THE ISSUE CAME UP?: D-3 WEEKS AFTER PROCEDURE 4. DID THE PROCEDURE PROLONG? BY HOW MANY MINUTES? INITIAL PROCEDURE WAS NOT PROLONGED. 5. HOW DID THE USER PROCEED WHEN THE ISSUE CAME UP? PATIENT HAS BEEN SCOPED A SECOND AND THIRD TIME TO ATTEMPT REMOVAL OF THE FRACTURED STENT. 6. WHAT WAS THE PROCEDURE OUTCOME? THE PORTION OF STENT THAT HAS MIGRATED INTO THE SMALL BOWEL WAS UNABLE TO BE RETRIEVED CAUSING A SMALL BOWEL OBSTRUCTION AND REQUIRING FURTHER INTERVENTION. WVU HAS ALERTED THEIR LEGAL COUNSEL WHO HAS ADVISED THEM NOT TO RETURN THE DAMAGED STENT TO OLYMPUS FOR INVESTIGATION.

    Description of Event or Problem · 0

    PLEASE REFER TO CUSTOMER'S RESPONSE BELOW: WHAT IS THE DATE OF THE EVENT?: THE STENT WAS ORIGINALLY PLACED ON (B)(6). ON (B)(6) THE PATIENT WENT TO THE ER WITH ABDOMINAL PAIN. WHAT WAS THE MODEL OF THE STENT ITSELF?: ECBA-20-15-230, LOT #24101229 WAS THERE A DEATH RELATED TO THIS ISSUE?: NO, NOT AT THIS TIME. PATIENT IS STABLE. WAS THERE AN INFECTION OR SUSPECTED INFECTION RELATED TO THIS EVENT?: NO, NOT AT THIS TIME. PATIENT IS STABLE. WAS THERE A POSITIVE CULTURE TEST FINDING RELATED TO ANY DEVICES RELATED TO THIS ISSUE?: N/A WHERE WAS THE ISSUE FIRST DISCOVERED? (PROCEDURE, PREPARATION FOR USE, REPROCESSING, TESTING AND MAINTENANCE, RECEIPT AND INSPECTION, INSTALLATION)?: ON (B)(6) S/P ABD PAIN WHEN PT WENT TO ER. IF THE ISSUE OCCURRED DURING THE PROCEDURE: 1. WHAT WAS THE NAME OF THE PROCEDURE?: INITIAL PROCEDURE WHEN STENT WAS PLACED ON (B)(6) - EGD FOR H/O GASTRIC ULCER PERF S/P SUTURING W TRANSPYLORIC STENT PLACEMENT SCHEDULED FOR REMOVAL AFTER 4 WEEKS. 2. WAS THE PROCEDURE THERAPEUTIC OR DIAGNOSTIC?: THERAPEUTIC 3. AT WHAT POINT OF THE PROCEDURE DID THE ISSUE CAME UP?: D-3 WEEKS AFTER PROCEDURE 4. WAS THE PROCEDURE PROLONG? BY HOW MANY MINUTES?: INITIAL PROCEDURE WAS NOT PROLONGED. 5. HOW DID THE USER PROCEED WHEN THE ISSUE CAME UP?: PATIENT HAS BEEN SCOPED A SECOND AND THIRD TIME TO ATTEMPT REMOVAL OF THE FRACTURED STENT. 6. WHAT WAS THE PROCEDURE OUTCOME?: THE PORTION OF STENT THAT HAS MIGRATED INTO THE SMALL BOWEL WAS UNABLE TO BE RETRIEVED CAUSING A SMALL BOWEL OBSTRUCTION AND REQUIRING FURTHER INTERVENTION. WVU HAS ALERTED THEIR LEGAL COUNSEL WHO HAS ADVISED THEM NOT TO RETURN THE DAMAGED STENT TO OLYMPUS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775474 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-150-230 24101229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention