BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR

    MDR report key: 14190520 · Received April 22, 2022

    Report

    Report Number
    9610773-2022-00151
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 27, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020978
    PMA / PMN Number
    K931994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ADDITIONAL 510K: K931995. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2951238-2022-00389.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H6, H10. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO THERMAL MECHANICAL OVERLOAD, IMPROPER HANDLING, MECHANICAL IMPACT LIKE FALL, SHOCK OR SIMILAR STRESS. ALSO NOTE THAT THE CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO WEAR AND TEAR. PLEASE NOTE THAT SIGNS OF FATIGUE OR PRE-DAMAGE, SUCH AS MINUTE CRACKS, ARE OFTEN HARD TO SPOT.

    Description of Event or Problem · 0

    OLYMPUS WAS NOTIFIED OF THE EVENT FROM THE CUSTOMER VIA MW5107602. DURING A CYSTOSCOPY TRANSURETHRAL RESECTION OF THE PROSTATE, THE TIP OF THE SWIVEL OBTURATOR ON THE SCOPE BROKE OFF IN THE PATIENT. THE BROKEN TIP WAS RETRIEVED AND NO PIECES WERE LEFT IN THE PATIENT. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE. THE CUSTOMER REPORTED THIS MALFUNCTION OCCURRED AT THE END OF THE PROCEDURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PROCEDURAL DELAY, NO CHANGE IN THE PATIENT'S TREATMENT COURSE DUE TO THE MALFUNCTION AND NO POST-OPERATIVE ISSUES WITH THE PATIENT DUE TO THIS ISSUE. THE CUSTOMER REQUESTED A RE-EDUCATION ON THE PROPER HANDLING OF THIS DEVICE AND THERE HAVE NOT BEEN ANY FURTHER ISSUES SINCE TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741666 RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR SCOPE HIH OLYMPUS WINTER & IBE GMBH A22041T UNKNOWN 04042761020978

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other