BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOON FORCEPS LONG,SERRAT

    MDR report key: 15950861 · Received December 9, 2022

    Report

    Report Number
    1216677-2022-00320
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 9, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X- INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM REDA INSTRUMENTE - GMBH ON 6/15/2020. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW IQC RECORD-20-06-16-003 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. THE SCISSOR IS BROKEN. PRODUCT RECEIPT THE COMPLAINT PRODUCT (ES-LNGR-CE, 1) WAS RETURNED. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE AT THE SCISSOR JOINT, PLEASE SEE ATTACHED PICTURE. FUNCTIONAL EVALUATION COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED BY THE VENDOR AND FOUND NOT TO FUNCTION PROPERLY. PLEASE SEE THE VENDOR REPORT IN THE ATTACHMENT. ROOT CAUSE WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE OVERLOAD. THE RIVET HAS DEFORMED DUE TO THE EXCESSIVE LOAD. DUE TO EXCESSIVE PRESSURE ON THE LEVER POINT, THE AXLE HAS DEFORMED AND SUBSEQUENTLY LOOSENED. THIS IS AN INDICATION THAT THE INSTRUMENT WAS HANDLED INCORRECTLY. CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    WHEN REMOVING PATHOLOGICAL LESION WITH THE SPOON FORCEPS LONG, THE LINE ATTACHED TO THE SERRATED ARMS OF THE FORCEPS IN THE SPIRAL-REINFORCED CANNULA PROBABLY BROKEN. FOLLOW-UP RESPONSE: THE PROBLEM APPAIRED DURING PROCEDURE. THE DOCTOR WAS UNABLE TO COMPLETE PROCEDURE WITH ENDOSEE ADVANCE. PATIENT WAS UNDER GENERAL ANESTHESIA. 1216677-2022-00320 SPOON FORCEPS LONG SERRAT ES-LNGR-CE (B)(4).

    Description of Event or Problem · 0

    WHEN REMOVING PATHOLOGICAL LESION WITH THE SPOON FORCEPS LONG, THE LINE ATTACHED TO THE SERRATED ARMS OF THE FORCEPS IN THE SPIRAL-REINFORCED CANNULA PROBABLY BROKEN. FOLLOW-UP RESPONSE: THE PROBLEM APPAIRED DURING PROCEDURE. THE DOCTOR WAS UNABLE TO COMPLETE PROCEDURE WITH ENDOSEE ADVANCE. PATIENT WAS UNDER GENERAL ANESTHESIA. SPOON FORCEPS LONG SERRAT ES-LNGR-CE E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886358 SPOON FORCEPS LONG,SERRAT SPOON FORCEPS LONG,SERRAT FCL COOPERSURGICAL, INC. ES-LNGR-CE 639138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other