BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX. GRASP. FORCEPS 6.6FR WL 550MM

    MDR report key: 18364762 · Received December 20, 2023

    Report

    Report Number
    9611102-2023-00074
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FCL
    UDI-DI
    04055207020289
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, WAS PRODUCED ON MARCH 22, 2021 WITH THE LOT NUMBER 4500330894. THE BATCH SIZE WAS 13 UNITS. THERE HAVE BEEN 2 COMPLAINTS RELATED TO THIS BATCH NUMBER WITH A SIMILAR ISSUE SINCE THEN AND INCLUDING THIS CASE. THE USER FACILITY STATED THAT THE INSTRUMENT WITH THIS LOT NUMBER HAS BEEN UTILIZED APPROXIMATELY 20 SPLINT REMOVALS IN THE PAST 2 YEARS AND 3 MONTHS.

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING AN FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, LOT # 4500330894. ACCORDING TO THE RECEIVED INFORMATION, A PROCEDURE TO REMOVE THE URETERAL STENT WAS PLANNED USING THE SURGICAL INSTRUMENT. "AFTER INSERTION INTO THE WORKING CHANNEL, THE FORCEPS WERE OPENED TO GRIP THE SPLINT. WHEN GRIPPING/CLOSING, THE JAWS BLOCKED. FORCEPS DID NOT CLOSE. AFTER ACTUATING THE GRIPPING DEVICE SEVERAL TIMES, THE FORCEPS FINALLY CLOSED. WE REMOVED THE FORCEPS AND ABORTED THE PROCEDURE TO PREVENT IT FROM BLOCKING AGAIN. THE INSTRUMENT WAS CHECKED FOR INTEGRITY BEFORE STERILIZATION. ALSO IMMEDIATELY BEFORE USE ON THE PATIENT. IT THEN FAILED DURING THE PROCEDURE." THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954049 FLEX. GRASP. FORCEPS 6.6FR WL 550MM FCL RICHARD WOLF GMBH 8736685 4500330894 04055207020289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other