BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 11693196 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05150
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 6, 2024
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    UDI-DI
    04953170403019
    PMA / PMN Number
    K193182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE MANUFACTURER¿S INVESTIGATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED DURING THIS INVESTIGATION. ADDITIONALLY, THE CUSTOMER INITIALLY PROVIDED LOT NUMBER '2021143' HOWEVER, THIS IS NOT A VALID LOT NUMBER WITH OLYMPUS. THE IFU FOR THE DEVICE PROVIDES THE FOLLOWING INFORMATION REGARDING THIS EVENT ¿PLEASE MAKE SURE THAT THE DISTAL COVER IS INTACT WITHOUT ANY PROBLEM BEFORE INSTALLATION, AND IT HAS NO DAMAGE(CRACK) AFTER INSTALLATION. ALSO, DO NOT USE ANTI-FOG AGENTS AS IT IS KNOWN THAT ANTI-FOG AGENTS WILL DAMAGE THE COVER.¿ A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED THROUGH THE INVESTIGATION. HOWEVER, BASED ON THE INFORMATION PROVIDED, IT IS BELIEVED THAT ONE OF THE FOLLOWING CAUSED THE REPORTED EVENT: AN ANTI-FOG AGENT ADHERED TO THE COVER AND WAS DAMAGED BY A CHEMICAL ATTACK, MAKING IT EASY FOR THE TOP COVER TO COME OFF THE SCOPE. THE COVER WAS EASILY REMOVED FROM THE SCOPE DUE TO INSUFFICIENT ATTACHMENT TO THE SCOPE. WHEN THE COVER WAS ATTACHED TO THE SCOPE, IT WAS DAMAGED BY UNINTENTIONALLY APPLYING DIAGONAL PRESSURE, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION TO B7, D4, G2, AND H6. B7/G2(HCP): INFORMATION ADDED TO THESE FIELDS WERE INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS INVALID. LOT INFORMATION "2021143" WAS PROVIDED AT THE TIME OF INITIATING, BUT SUCH A LOT DOES NOT EXIST. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. 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. (MAJ-2315 LOT H0729 WAS USED FOR REPRODUCTION CONFIRMATION). THE PARTS SUPPLIER CONDUCTS SAMPLING INSPECTIONS OF THREE (3) PARTS FOR EACH PRODUCTION LOT AND CONFIRMED THE PARTS CONFORMED TO THE SPECIFICATIONS. QUALITY EVALUATIONS OF PRODUCTION PROTOTYPES HAVE VERIFIED THAT THE DISTAL COVER WILL NOT COME OFF FROM THE ENDOSCOPE UNLESS THE DISTAL COVER IS DAMAGED, AS LONG AS IT IS PROPERLY ATTACHED WITHOUT ANY DAMAGE. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. BASED ON THE REPRODUCTION CONFIRMATION RESULTS, INVESTIGATION RESULTS OF PRODUCT SPECIFICATIONS, AND THE INSPECTION RESULTS AT THE PARTS MANUFACTURER, IT IS BELIEVED THAT THE PRODUCT CONFORMED TO THE SPECIFICATIONS. HOWEVER, THE ACTUAL PRODUCT HAD NOT BEEN RETURNED, AND THE DETAILS OF THE OCCURRENCE SITUATION COULD NOT BE CONFIRMED, THEREFORE, THE CAUSE COULD NOT BE DETERMINED. THE PROBABLE CAUSE WAS LIKELY THE FOLLOWING: -CHEMICALS SUCH AS ANTI-FOG AGENTS ADHERED TO THE COVER AND WERE DAMAGED BY CHEMICAL ATTACK, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. -THE COVER WAS EASILY REMOVED FROM THE SCOPE DUE TO INSUFFICIENT ATTACHMENT TO THE SCOPE. -WHEN THE COVER WAS ATTACHED TO THE SCOPE, THE COVER WAS DAMAGED BY PUSHING IT DIAGONALLY, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. COMPLAINT HISTORY REVIEW: A SIMILAR COMPLAINT FROM ANOTHER FACILITY WAS PATIENT IDENTIFIER C21160153. THERE WAS NO SIMILAR COMPLAINT AT THE SAME FACILITY. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING GUIDELINES: AS DESCRIBED IN THE IFU "7.3 ATTACHING THE DISTAL COVER" (P.11 TO P.13): PLEASE MAKE SURE THAT THE DISTAL COVER IS INTACT WITHOUT ANY PROBLEM BEFORE INSTALLATION, AND IT HAS NO DAMAGE(CRACK) AFTER INSTALLATION. ALSO, DO NOT USE ANTI-FOG AGENTS AS IT IS KNOWN THAT ANTI-FOG AGENTS WILL DAMAGE THE COVER. 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 3003637092.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY. THE FACILITY REPORTED THAT THE PROCEDURE THAT WAS BEING PERFORMED WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COVER BUT WITH THE SAME SCOPE, MODEL NUMBER TJF-Q190V, SERIAL NUMBER (B)(6). PRODUCT INFORMATION FOR THE REPLACEMENT COVER WAS NOT PROVIDED. IT IS UNKNOWN IF THE EDGES OF THE COVER WERE SHARP OR EXPOSED WHEN IT FELL OFF THE SCOPE. ACCORDING TO THE FACILITY, IF THE COVER HAD FALLEN INTO THE PATIENT, IT WOULD HAVE FALLEN INTO THEIR STOMACH. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS. THE PRE-EXISTING CONDITION OF THE PATIENT AT THE TIME OF THE PROCEDURE WAS OBD. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION BECOMES PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SINGLE USE DISTAL COVER'S TIP DETACHED DURING A PROCEDURE. ACCORDING TO THE INITIAL REPORTER, WHEN THEY REMOVED THE CAP FROM THE PATIENT, THE DISTAL TIP WAS NOT PRESENT. REQUESTS WERE MADE TO THE USER ON WHETHER THE SEGMENT WAS STILL IN THE PATIENT. THE DOCTOR STATED THAT IF THE TIP IS STILL IN THE PATIENT, IT WILL PASS. THE NURSE WENT ON TO NOTE THAT SHE FOLLOWED UP WITH THE PATIENT TWO DAYS POST PROCEDURE, AND THEY WEREN'T EXPERIENCING ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595887 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 UNK 04953170403019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MODEL NUMBER: TJF-Q190V .SERIAL NUMBER : (B)(6).