BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTION SHEATH, 26 FR.

    MDR report key: 16701703 · Received April 7, 2023

    Report

    Report Number
    9610773-2023-00993
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    October 20, 2022
    Report Date
    April 7, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020985
    PMA / PMN Number
    K931994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: ADDITIONAL 510K NUMBER AS IT WAS UNKNOWN IF THE RESECTION SHEATH WAS USED FOR A GYNECOLOGICAL OR UROLOGICAL INDICATION - K931995. THE ISSUE REPORTED BY THE CUSTOMER WAS EVALUATED/INVESTIGATED AS PLAUSIBLE. ACCORDING TO THE EVENT DESCRIPTION, A FRAGMENT OF THE TIP OF THE SHEATH BROKE OFF AND FELL INTO THE PATIENT. IT IS LIKELY THAT THE REPORTED DAMAGE WAS MOST PROBABLY INDUCED BY THERMO-MECHANICAL FATIGUE. IT COULD NOT BE DETERMINED WHETHER THERE WAS ADVANCED WEAR AND TEAR OR PRE-EXISTING DAMAGE. FURTHERMORE, IT COULD NOT BE DETERMINED WHETHER THE FINAL DAMAGE WAS TRIGGERED IN THE COURSE OF THE PROCEDURE OR DURING REPROCESSING. IN CASE THERE WERE DOUBTS WHETHER FRAGMENTS OF THE INSULATING INSERT REMAINED INSIDE THE PATIENT, OSTE RECOMMENDS AN EXPLORATORY X-RAY OR COMPUTED TOMOGRAPHY. AS A GENERAL NOTE, CRACKS ON THE INSULATION MATERIAL ARE MOSTLY NOT VISIBLE, MAKING VISUAL INSPECTION DIFFICULT. DESPITE BEST EFFORTS, THE LOT/SERIAL NUMBER FOR THE AFFECTED DEVICE COULD NOT BE OBTAINED. THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. BEFORE USING THE PRODUCT, THE WARNING NOTICES IN THE INSTRUCTIONS FOR USE SHOULD BE FOLLOWED TO ENSURE A FAULTLESS CONDITION OF THE PRODUCT. SEE ESPECIALLY CHAPTER 4: WARNING. 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. 4.1 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. THIS REPORT WAS SUBMITTED BY THE IMPORTER UNDER THE IMPORTER'S REPORT NUMBER: 2429304-2023-00062. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED A VOLUNTARY MEDWATCH REPORT (MW5113231) STATING THAT A SMALL PIECE OF THE RESECTION SCOPE WAS FOUND BY THE SURGEON IN THE PATIENT. THE BROKEN PIECE WAS RETRIEVED, AND NO HARM OCCURRED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, BUT WAS NOT RECIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415611 RESECTION SHEATH, 26 FR. ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22042A UNKNOWN 04042761020985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention