BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 12223497 · Received July 26, 2021

    Report

    Report Number
    8010047-2021-09305
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    June 27, 2021
    Report Date
    May 6, 2024
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    EOQ
    UDI-DI
    14953170152433
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DISPOSABLE BIOPSY VALVE MAJ-210 WITH LOT NUMBER H0917 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) VIA OLYMPUS EUROPA SE & CO. KG. THE BIOPSY VALVE MAJ-210 COULD BE ATTACHED TO THE SCOPE OPERATION PART INSPECTION TOOL (K01324) WITHOUT ANY DAMAGES. OMSC DETERMINED THAT THE BIOPSY VALVES MAJ-210 WAS DAMAGED BECAUSE THE USER DID NOT COMPLY WITH THE INSTRUCTION "PUT THE BIOPSY VALVE ON THE CHANNEL PORT AND PUSH THE UPPER PART OF THE BIOPSY VALVE DOWN SLANTINGLY ONTO THE CHANNEL PORT" DESCRIBED IN SECTION 7.3 "ATTACHING THE BIOPSY VALVE TO THE ENDOSCOPE" IN THE INSTRUCTION MANUAL. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    INFORMATION FOR THESE FIELDS WERE INADVERTENTLY NOT INCLUDED ON THE INITIAL AND SUPPLEMENTAL MEDWATCHES. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A REPRODUCTION CONFIRMATION WAS PERFORMED ACCORDING TO THE PRE-USE INSPECTION PROCEDURE IN SECTION 7.3 OF THE INSTRUCTION MANUAL. THE INDICATED EVENT WAS NOT REPRODUCED. "THE HOUSING OF THE FORCEPS PLUG MUST NOT BE DAMAGED WHEN ATTACHED" IS VERIFIED BY EVALUATION BASED ON PRODUCT STANDARDS. IN THE FINAL INSPECTION PROCESS, 9 SAMPLING INSPECTIONS ARE CARRIED OUT FOR EACH PRODUCTION LOT, AND IT IS CONFIRMED THAT THE GROOVE IS NOT TORN WHEN ATTACHED TO THE MOUTHPIECE IN COMBINATION WITH THE SCOPE. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. BASED ON THE PRODUCT SPECIFICATION INVESTIGATION AND THE INSPECTION RESULTS OF THE FINAL INSPECTION PROCESS, NO ABNORMALITIES WERE FOUND IN THE PRODUCT AT THE DESIGN AND MANUFACTURING STAGES, AND IT WAS FOUND THAT THE HOUSING WOULD NOT BE DAMAGED IF INSTALLED ACCORDING TO THE REGULAR PROCEDURE. HOWEVER, THE DETAILED SITUATION AT THE TIME OF OCCURRENCE COULD NOT BE CONFIRMED, SO THE CAUSE OF THE EVENT THAT OCCURRED AT THE FACILITY COULD NOT BE DETERMINED. THE PROBABLE CAUSE WAS LIKELY THE FOLLOWING: THE DEVICE WAS DAMAGED DUE TO FAILURE TO INSTALL ACCORDING TO THE 7.3 IN THE INSTRUCTIONS FOR USE (IFU) MANUAL. COMPLAINT HISTORY REVIEW: THE EVENT WAS THE FIRST OCCURRENCE AT THE FACILITY. A SIMILAR COMPLAINT FROM ANOTHER FACILITY WAS PATIENT IDENTIFIER (B)(6). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING GUIDELINES: 7.3 ATTACHING THE BIOPSY VALVE TO THE ENDOSCOPE: PUT THE BIOPSY VALVE ON THE SUCTION VALVE HOLDER OR THE INSTRUMENT CHANNEL PORT WITH ITS TAB NEAR SIDE IN THE ILLUSTRATED DIRECTION. PUSH THE UPPER PART OF THE BIOPSY VALVE DOWN SLANTINGLY ONTO THE SUCTION VALVE HOLDER OR THE INSTRUMENT CHANNEL PORT UNTIL THE VALVE SNAPS INTO PLACE. OLYMPUS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    ELEVEN UNUSED BIOPSY VALVES MAJ-210 WITH LOT NUMBER H0917 HAVE BEEN RETURNED TO OLYMPUS (B)(6). THESE BIOPSY VALVES ARE PLANNED TO BE SENT TO OMSC FOR INVESTIGATION VIA OLYMPUS (B)(6). THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING THE PREPARATION FOR USE, WHEN THE SINGLE USE BIOPSY VALVE MAJ-210 WAS ATTACHED TO THE OLYMPUS BRONCHOSCOPE BF-P160, THE BIOPSY VALVE MAJ-210 WAS BROKEN. THE BIOPSY VALVE MAJ-210 WAS REPLACED DUE TO DAMAGE AND WAS USED FOR ENDOSCOPY WITH A BIOPSY. THE PROCEDURE THAT NORMALLY TAKES 30 MINUTES HAS BEEN EXTENDED BY 5 MINUTES, DUE TO THE OCCURRENCE OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122357 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-210 H0917 14953170152433

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male BF-P160, S/N: UNK.