BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOON FORCEPS LONG,SERRAT

    MDR report key: 12168606 · Received July 14, 2021

    Report

    Report Number
    1216677-2021-00140
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    November 14, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **CORRECTED DATA IN SECTIONS B5 AND E1** INVESTIGATION X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM REDA INSTRUMENTE - GMBH. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE A2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT ES-LNGR WAS RETURNED. VISUAL EVALUATION VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED FOR INVESTIGATION AND FOUND NOT TO FUNCTION PROPERLY. COMPLAINT PRODUCT WAS FORWARDED TO SUPPLIER INSTRUMENTE - GMBH UNDER SCAR# ((B)(4)). ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. *CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    (B)(4). *WHAT ARE THE DETAILS OF THE COMPLAINT? IS THERE ANYTHING ELSE? DEVICE CAME APART. *HOW IS PATIENT TODAY? NA. *WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NA. *WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? NA. *DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? NA. 1216677-2021-00140. SPOON FORCEPS LONG SERRAT ES-LNGR (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    DEVICE CAME APART. SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067613 SPOON FORCEPS LONG,SERRAT SPOON FORCEPS LONG,SERRAT HFB COOPERSURGICAL, INC. ES-LNGR 643022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other