BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

    MDR report key: 16997205 · Received May 24, 2023

    Report

    Report Number
    9610773-2023-01421
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    May 25, 2022
    Report Date
    September 13, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761068205
    PMA / PMN Number
    K120418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - APPROXIMATE DATE OF (B)(6) 2022 WAS USED AS THE EVENT REPORTEDLY OCCURRED ABOUT A YEAR PRIOR TO NOTIFICATION. G4 - ADDITIONAL FDA PREMARKET SUBMISSION NUMBER: K100275 . THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT THE CUSTOMER CONFIRM NO OTHER EVENT DETAILS CAN BE PROVIDED. 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT MAY BE ATTRIBUTED TO PROCEDURAL COMPLICATION DURING OPERATION. DURING RESECTION, CUTTING AND COAGULATION AN EXPLOSIVE COMPOUND OF HYDROGEN (H2) AND OXYGEN (O2), ALSO KNOWN AS OXYHYDROGEN, IS GENERATED BY THERMAL REACTION OF THE RINSING LIQUID. ACTIVATION OF THE HF CURRENT IN THE PRESENCE OF INFLAMMABLE GASES MAY CAUSE THE GASES TO IGNITE OR EXPLODE. THIS MAY RESULT IN BLADDER PERFORATION OR PUNCTURE, EXOGENOUS BURNS OR OTHER INJURIES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT A PATIENT EXPERIENCED "BLADDER EXPLOSION" DURING A TRANSURETHERAL RESECTION OF THE PROSTATE WHILE USING A HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE, 12 PCS., FOR TURIS. THE EVENT REPORTEDLY OCCURRED ABOUT A YEAR PRIOR TO NOTIFICATION. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949320 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS OLYMPUS WINTER & IBE GMBH WA22503D UNKNOWN 14042761068205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other TURIS SET| VIO (MODEL UNKNOWN)