BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDE SHEATH KIT

    MDR report key: 11458365 · Received March 11, 2021

    Report

    Report Number
    8010047-2021-03571
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    February 17, 2021
    Report Date
    April 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K060243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE GUIDE SHEATH (SG-200C) AND THE ULTRASONIC PROBE WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE LOT NUMBER OF THE GUIDE SHEATH (SG-200C) WAS "0YK". THERE WAS NO BUCKLING OR DEFORMATION OF THE TUBE AT THE TIP OF THE GUIDE SHEATH. THERE WAS AN INDENTATION AT ABOUT 6 CM FROM THE TIP OF THE GUIDE SHEATH. THERE WERE TWISTS AT ABOUT 60 CM AND 100 CM FROM THE TIP OF THE ULTRASONIC PROBE. THE TIP SHEATH HAD FALLEN OFF AT ABOUT 6 CM FROM THE TIP OF THE ULTRASONIC PROBE. IN ADDITION, THERE WERE SCRATCHES AROUND THE DROPPED PART. THERE WERE NO OTHER ABNORMALITIES THAT COULD LEAD TO THE REPORTED EVENT. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE INNER BLADE OF THE ULTRASONIC PROBE COULD NOT BE DRIVEN NORMALLY, SO THAT THE SHEATH WAS TWISTED AND THE TIP PART FELL OFF. [GENERATION MECHANISM] *THE FRACTURE SURFACE OF THE TIP SHEATH SHOWED THAT IT WAS THREADED AND CUT OFF. THERE WAS NO TRACE OF BEING CUT BY A KNIFE. THEREFORE, IT WAS PRESUMED THAT THE INTERNAL BLADE COULD NOT BE DRIVEN NORMALLY AND THE INSIDE OF THE SHEATH WAS CAUGHT AND TWISTED. *SINCE SCRATCHES WERE FOUND AROUND THE SHEATH THAT FELL OFF, IT INDICATED THAT THE INTERNAL BLADE COULD NOT BE DRIVEN NORMALLY AND WAS BUFFERED WITH THE BLADE INSIDE THE SHEATH. *THE INDENTATION ON THE K-201 GUIDE SHEATH WAS AT ABOUT 6 CM FROM THE TIP, WHICH WAS THE SAME AS THE DROPPED PART OF THE ULTRASONIC PROBE UM-S20-17S. AT THE TIME THEY WERE MADE, IT WAS PRESUMED THAT THE INTERNAL BLADE COULD NOT BE DRIVEN NORMALLY. REGARDING THE CATCHING OF THE ULTRASONIC PROBE, IT WAS THOUGHT THAT THE FRICTIONAL RESISTANCE BETWEEN THE GUIDE SHEATH AND THE ULTRASONIC PROBE INCREASED DUE TO THE COMPRESSION OF THE GUIDE SHEATH, AND IT FELT LIKE IT WAS CAUGHT. REGARDING BLEEDING, IT WAS ASSUMED THAT THE TIP OF THE ULTRASONIC PROBE WAS DAMAGED BY BENDING, HITTING, PULLING, OR TWISTING WITH A STRONG FORCE, AND THE INSIDE OF THE BODY CAVITY COULD BE INJURED AND BLEEDING OCCURRED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE AS FOLLOWS. *DO NOT OPERATE THE TREATMENT TOOL WITH EXCESSIVE FORCE. IT MAY LEAD TO DAMAGE TO THE TREATMENT TOOL. *DO NOT BEND, HIT, PULL, TWIST, OR DROP THE TIP, INSERTION, OR CONNECTION OF THE PROBE WITH STRONG FORCE. THE EQUIPMENT MAY BE DAMAGED, CAUSING DAMAGE TO THE BODY CAVITY, BURNS, BLEEDING, PERFORATION, OR LOSS OF PARTS. *DO NOT INSERT OR REMOVE THE PROBE WITH EXCESSIVE FORCE. ALSO, DO NOT INSERT OR REMOVE IT SUDDENLY. IT MAY DAMAGE THE INSIDE OF THE BODY CAVITY, CAUSE BLEEDING OR PERFORATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC ULTRASONOGRAPHY BEFORE BIOPSY AND BRUSHING CYTOLOGY, THE SUBJECT DEVICE WAS USED IN COMBINATION WITH UM-S20-17S WHICH WAS NEW AND USED FOR THE FIRST TIME. THE PATIENT WAS SUSPECTED OF LUNG CANCER. AFTER THE PROCEDURE WAS STARTED, THE ULTRASOUND IMAGE APPEARED NORMALLY AT FIRST, BUT IT BECAME DIFFICULT TO SEE. THE DOCTOR FELT THAT UM-S20-17S GOT STUCK WHEN TRYING TO PULL IT OUT. WHEN THE DOCTOR PULLED IT OUT, IT WAS FOUND THAT BRONCHUS WAS BLEEDING. THE PHYSICIAN DETECTED THAT THE TIP OF THE ULTRASOUND TRANSDUCER OF UM-S20-17S WAS MISSING. FOREIGN MATERIAL SEEMED TO BE THE FRAGMENT OF ULTRASOUND TRANSDUCER WAS FOUND INSIDE THE PATIENT UNDER FLUOROSCOPY AND RETRIEVED. IT WAS ABOUT 3 CM SIZE, AND LOOKED LIKE A STRETCHED VINYL. IT COULD NOT BE PROVIDED TO OLYMPUS BECAUSE IT WOULD BE ANALYZED IN THE HOSPITAL. THE PATIENT WAS TRANSFERRED TO THE ICU FOR HEMOSTASIS. THE DOCTOR STATED THAT BLEEDING COULD BE STOPPED. THE NURSE STATED THAT THERE WAS NO ABNORMALITY DURING REPROCESSING UM-S20-17S BEFORE USE. IN ADDITION, IT WAS REPORTED THAT THE MULTIPLE DOCTORS SET UP UM-S20-17S WITH THE SUBJECT DEVICE, K-201. THERE WERE COMMENTS THAT THE PROBE MIGHT HAVE BEEN THINNER THAN USUAL. HOWEVER, IT WAS NOT REPORTED THAT THE MALFUNCTION OF THE SUBJECT DEVICE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363413 SINGLE USE GUIDE SHEATH KIT SINGLE USE GUIDE SHEATH EOQ OLYMPUS MEDICAL SYSTEMS CORP. K-201

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention