BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOON FORCEPS LONG,SERRAT

    MDR report key: 14392303 · Received May 13, 2022

    Report

    Report Number
    1216677-2022-00147
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 28, 2022
    Report Date
    September 16, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CONDITION IS BEING INVESTIGATED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS , DISTRIBUTION HISTORY, THE COMPLAINT PRODUCT WAS PURCHASED FROM REDA INSTRUMENTE - GMBH ON (B)(6) 2021. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW: IQC RECORD-21-06-14-027 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED SERVICE HISTORY RECORD : SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. HOWEVER, FROM SIMILAR INCIDENTS, THE POTENTIAL CAUSE MAY BE MISHANDLING BY THE END USER, WHICH CAUSED THE DIFFICULTY OF OPENING/CLOSING THE INSTRUMENT. PRODUCT RECEIPT: THE COMPLAINT PRODUCT (ES-LNGR, 1 PC) WAS RETURNED ON 08-23-22. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY, OPEN AND CLOSE EASILY. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION /PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    REPORT STATED "DURING THE PROCEDURE THE DOCTOR WAS GOING TO GRAB SOME TISSUE WITH THE FORCEPS AND THE JAW WOULDN'T OPEN/IN THE MIDDLE OF THE PROCEDURE THE FORCEPS WOULDN'T GRASP. " PROCEDURE BEING PERFORMED -HYSTEROSCOPY. PATIENT IS GOOD. NO ADVERSE EVENT REPORTED. 1216677-2022-00147 SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    REPORT STATED "DURING THE PROCEDURE THE DOCTOR WAS GOING TO GRAB SOME TISSUE WITH THE FORCEPS AND THE JAW WOULDN'T OPEN/IN THE MIDDLE OF THE PROCEDURE THE FORCEPS WOULDN'T GRASP. " PROCEDURE BEING PERFORMED -HYSTEROSCOPY. PATIENT IS GOOD. NO ADVERSE EVENT REPORTED. 1216677-2022-00147 SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309898 SPOON FORCEPS LONG,SERRAT SPOON FORCEPS LONG,SERRAT HFB COOPERSURGICAL, INC. ES-LNGR 644932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other