BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 14407324 · Received May 16, 2022

    Report

    Report Number
    8010047-2022-08303
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 9, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE OLYMPUS SERVICE CENTER EVALUATED THE DEVICE AND THE REAR END WAS FOUND TO BE CRACKED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION TO E1 AND H6. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE, SINCE THE LOT NUMBER WAS NOT PROVIDED. 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#: H1412 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 RETURNED DISTAL COVER WAS DAMAGED ON THE REAR END SIDE. AND IT WAS CONFIRMED, THAT IT WAS IN A STATE, WHERE IT WAS EASY TO COME OFF THE SCOPE. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. BASED ON THE VISUAL CONFIRMATION RESULTS, 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 CAUSE COULD NOT BE DETERMINED. THE PROBABLE CAUSE WAS LIKELY THE FOLLOWING: BECAUSE SOME LOAD WAS APPLIED TO THE TIP COVER, BEFORE AND AFTER MOUNTING ON THE SCOPE. AND IT WAS DAMAGED. IT BECAME INSUFFICIENTLY FIXED TO THE SCOPE. THEREFORE, THE COVER CAME OFF, DUE TO FRICTION WITH THE INSIDE OF THE BODY CAVITY, WHEN THE SCOPE WAS REMOVED. 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: 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 SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. OLYMPUS TRIED TO REPLICATE THE REPORTED FAILURE USING A DISTAL COVER (LOT. H1412) AND CONFIRMED THAT THE DISTAL COVER WILL NEVER COME OFF WHEN IT HAS NO DAMAGE, AND IT IS CORRECTLY ATTACHED TO THE SCOPE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO THE LOAD APPLIED TO THE TIP COVER BEFORE AND AFTER MOUNTING ON THE SCOPE AND IT WAS DAMAGED, RESULTING IN INSUFFICIENTLY FIXED TO THE SCOPE. THEREFORE, THE COVER CAME OFF DUE TO FRICTION WITH THE INSIDE OF THE BODY CAVITY WHEN THE SCOPE WAS REMOVED. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AN INTERVIEW WAS CONDUCTED BY OLYMPUS WITH THE FACILITY AS PART OF THE ROOT CAUSE INVESTIGATION PER CAPA-200735. IT WAS CONFIRMED BY THE FACILITY THAT THERE HAS BEEN NO CHANGE IN THE STORAGE METHOD OF THE DISTAL COVERS SINCE EXPERIENCING THE DETACHMENT ISSUE. THE DISTAL COVER STERILIZATION PACKS ARE REMOVED FROM THE PRODUCT CARTON AND STORED IN A DRAWER. THE FACILITY DID NOT PROVIDE AN ANSWER TO WHETHER THE CHEMICALS USED DURING THE REPORTED INCIDENT (DETACHMENT OF THE DISTAL COVER) ARE KNOWN. HOWEVER, THEY STATED THAT THEY TYPICALLY APPLY SULPRO JELLY LUBRICANT TO THE DISTAL END OF THE ENDOSCOPE. NO DEFOGGER IS USED. GASCON (ABOUT 10CC GASCON DILUTED IN ABOUT 300CC WATER) IS ADMINISTERED DIRECTLY INTO THE BODY THROUGH THE FORCEPS CHANNEL DURING ENDOSCOPE INSERTION AND SENT TO THE FORCEPS CHANNEL TO LUBRICATE. CONTRAST (UROGRAFIN) AND PHYSIOLOGICAL SALINE ARE ADMINISTERED THROUGH THE CANNULA DURING THE ENDOSCOPE INSERTION. IF BLEEDING OCCURS, ADRENALINE (DILUTED WITH 20CC OF PHYSIOLOGICAL SALINE) IS ADMINISTERED. XYLOCAINE VISCUS IS ADMINISTERED ORALLY TO THE PATIENT BEFORE THE INSPECTION. ONLY TAP WATER (NO CHEMICALS) IS USED DURING ENDOSCOPE PREPARATION AND PRE-USE INSPECTION.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED, AFTER AN ERCP PROCEDURE, THE PATIENT FELT SICK THE NIGHT OF THE PROCEDURE AND VOMITED THE DISTAL END COVER ALONG WITH EMESIS. THE PATIENT STATED THERE WAS A CRACK ON THE 'HAND SIDE' OF THE DISTAL END COVER. THE FACILITY REPORTED THE PROCEDURE WAS COMPLETED AND IT WAS NOT IDENTIFIED THE DISTAL END CAP WAS MISSING AT THE END OF THE PROCEDURE AND WAS INADVERTENTLY LEFT IN THE PATIENT. THERE ARE 2 REPORTS FOR THIS EVENT: (B)(6): TJF-Q290V, 2111024. (B)(6): MAJ-2315. THIS REPORT IS 2 OF 2 FOR (B)(6): MAJ-2315.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091516 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 UNKNOWN 04953170403019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TJF-Q290V, SERIAL (B)(6).