BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTING TUBE

    MDR report key: 15831066 · Received November 19, 2022

    Report

    Report Number
    9610595-2022-04319
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 21, 2022
    Report Date
    March 14, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FEB
    UDI-DI
    04953170404092
    PMA / PMN Number
    K190969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE CORRECTED INVESTIGATION, THERE HAS SINCE BEEN A DESIGN CHANGE TO PREVENT REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    RELATED PATIENT IDENTIFIERS: THE CUSTOMER REPORTED THAT MULTIPLE CONNECTING TUBES WERE BAD. (B)(6) (ADDRESSES MODEL NUMBER MAJ-2110; LOT# 0YA), (B)(6) (ADDRESSES MODEL NUMBER MAJ-2112; LOT# 0ZA), (B)(6) (ADDRESSES MODEL NUMBER MAJ-2113; LOT# 0YA) (B)(6) (ADDRESSES MODEL NUMBER MAJ-2114; LOT# 0YA, (B)(6) (ADDRESSES MODEL NUMBER MAJ-2115; LOT# 0XA AND (B)(6) (ADDRESSES MODEL NUMBER MAJ-2330; LOT# 0XA). THE CUSTOMER REPORTED THAT THE CONNECTORS WILL BE RETURNED. HOWEVER, TO DATE, THE CONNECTING TUBE HAS NOT BEEN RETURNED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION, DEVICE EVALUATION, CUSTOMER FOLLOW-UP AND G3 CORRECTION. B5: UPDATED WITH INFORMATION RECEIVED FROM THE CUSTOMER. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 29-AUG-2022. THE SUBJECT DEVICE WAS MANUFACTURED IN NOVEMBER, 2010 BUT AN EXACT DATE IS UNAVAILABLE AS THE COMPLETE SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE COMPLETE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE OLYMPUS SERVICE CENTER RECEIVED THE RETURNED DEVICES AND CONFIRMED THE DAMAGED CONNECTING TUBE. BASED ON THE RESULTS OF THE DEVICE INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER, THIS ISSUE WAS FOUND TO LIKELY BE THE RESULT OF AN EXTERNAL LOAD APPLIED TO THE CLEANING TUBE, MAKING IT IMPOSSIBLE TO CONNECT. AN EXTERNAL LOAD ON THE IRRIGATION TUBE MAY BE CAUSED BY THE USER APPLYING FORCE IN THE WRONG DIRECTION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿ABNORMALITIES CAN BE DETECTED BY CONDUCTING THE FOLLOWING INSPECTIONS: 9. PREPARATION AND INSPECTION 2. MOVE THE LOCK LEVERS OF THE REPROCESSOR SIDE CONNECTOR TO MAKE SURE THAT THEY FUNCTION PROPERLY AND ARE NOT BROKEN¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THERE WERE MULTIPLES OER-ELITE CONNECTORS THAT WERE ¿BAD¿. THE CUSTOMER REPORTED THAT IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    CUSTOMER CONFIRMED ALL THE CONNECTORS BROKE AT THE METAL CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761743 CONNECTING TUBE ENDOSCOPE REPROCESSOR ACCESSORIES FEB AIZU OLYMPUS CO., LTD. MAJ-2114 0YA 04953170404092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown