BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 15058561 · Received July 19, 2022

    Report

    Report Number
    9610773-2022-00281
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 17, 2022
    Report Date
    August 23, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE HAS BEEN RETURNED TO DATE. THE STATUS OF THE DEVICE AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. THE INVESTIGATION IS ONGOING; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED PHENOMENON OCCURRED DUE TO THERMAL MECHANICAL OVERLOAD, IMPROPER HANDLING, MECHANICAL IMPACT LIKE FALL, SHOCK OR SIMILAR STRESS. IN ADDITION, THE CAUSE OF THE REPORTED ISSUES COULD BE ATTRIBUTED TO WEAR AND TEAR. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTION MANUAL STATE: - IFU STATES AS FOLLOWS: ¿INFECTION CONTROL RISK PROPERLY REPROCESS THE PRODUCT BEFORE FIRST AND EACH SUBSEQUENT USE FOLLOWING THE INSTRUCTIONS IN THIS MANUAL AND IN THE SYSTEM GUIDE ENDOSCOPY. IMPROPER AND/OR INCOMPLETE REPROCESSING CAN CAUSE INFECTION OF THE PATIENT AND/OR MEDICAL PERSONNEL. INSPECTION AND TESTING. INSPECTING THE PRODUCT. VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: NO CORROSION NO DENTS , NO SCRATCHES. CERAMIC INSULATION AT DISTAL END. VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS, FRACTURES). WARNING: RISK OF INJURY. IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END. DAMAGED INSTRUMENTS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. DO NOT USE THE INSTRUMENT IF DAMAGED. DAMAGED PRODUCT: IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    SALES REP. (B)(4), CALLED INTO TAC TO REPORT AN ISSUE WHERE THE CERAMIC TIP BROKE AND FELL INSIDE THE PATIENT. THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE PROCEDURE WAS COMPLETE. UPDATE: (B)(6) IS A DUPLICATE OF THIS ETQ RECORD (B)(6) ; DUPLICATE RECORD WILL BE CLOSED AS A NON-VALID COMPLAINT (SEE DUPLICATE CONFIRMATION RESPONSE ATTACHED ON 'EVALUATION' TAB). QIR RESULTS FOR DATASWEEP SERVICE ORDER (B)(4) FROM THE DUPLICATE RECORD WILL BE TRANSFERRED TO THIS ETQ RECORD UPON ESTIMATION COMPLETION. DW 494482/23JUN2022. UPDATE: 'EVENT FOUND AT' UPDATED FROM 'UNKNOWN' TO 'PROCEDURE' PER DATASWEEP SERVICE ORDER (B)(4) FROM DUPLICATE RECORD ((B)(6)). DW 494482/23JUN2022. UPDATE: UPDATED THE LOT NUMBER TO 177W-0074 PER SF CASE (B)(4). MYJ 407809 (B)(6) 2022. UPDATE: UPDATED REPORTING CONTACT (B)(4) POSITION TO MGR., TERRITORY - URO- #0511, OLYMPUS. UPDATED ¿EVENT FOUND AT¿ FROM ¿UNKNOWN¿ TO ¿PROCEDURE¿. UPDATED THE COMMON DEVICE NAME TO ¿ENDOSCOPE SHEATH, REUSABLE¿ PER ACCESSGUDID. MYJ 407809 JULY 1, 2022. DEVICE HAS NOT BEEN RECEIVED AS OF (B)(6) 2022. MYJ 407809 (B)(6) 2022. TIER 2, PAE IUC "THE CERAMIC TIP IS DAMAGED / PARTS BROKE OFF INSIDE THE PATIENT. / SND1002" AND PAE FUC "THE CERAMIC TIP IS DAMAGED / PARTS BROKE OFF INSIDE THE PATIENT. / SND1002" MYJ 407809 11JUL2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312693 INNER SHEATH, FOR 26 FR. OUTER SHEATH ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22040A 177W-0074 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown