BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOON FORCEPS LONG,SERRAT

    MDR report key: 10440633 · Received August 23, 2020

    Report

    Report Number
    1216677-2020-00188
    Event Type
    Malfunction
    Date Received
    August 23, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 23, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR COMPLAINTS OF LACK OF IUD HOCK REMOVAL. PRODUCT RECEIPT THE COMPLAINT PRODUCT (ES-LNGR, SPOON FORCEPS LONG, SERRAT, 1 EACH) WAS RETURNED UNDER RMA # (B)(4). VISUAL EVALUATION VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION COMPLAINT PRODUCT WAS FUNCTIONALY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE USER ERROR. *CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI REP. INCIDENT REPORT :"DR. (B)(6) SAID HE WENT TO USE HIS SPOON FORCEPS TO RETRIEVE AN IUD AND THE BITE WOULD NOT CLOSE. COMPLAINT WAS PLACED ON FRIDAY 7/31. HE WAS UNABLE TO COMPLETE HIS PROCEDURE BC THE DEVICE WAS INEFFECTIVE. HE TRIED TIGHTENING THE DIAL, OPEN AND CLOSE THE HANDLE. HE SAID IT DOES NOT WORK PROPERLY". PLEASE SEE ATTACHED FOR DETAILS. 08.17.2020- UPDATED WITH FOLLOW-UP RESPONSE- DR STATED "I TRIED TO ABOUT 5 MINUTE TO REMOVE A RETAINED IUD WHICH I WAS NOT ABLE TO DO". 1216677-2020-00188 SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI REP. INCIDENT REPORT :"DR. (B)(6) SAID HE WENT TO USE HIS SPOON FORCEPS TO RETRIEVE AN IUD AND THE BITE WOULD NOT CLOSE. COMPLAINT WAS PLACED ON FRIDAY (B)(6). HE WAS UNABLE TO COMPLETE HIS PROCEDURE BC THE DEVICE WAS INEFFECTIVE. HE TRIED TIGHTENING THE DIAL, OPEN AND CLOSE THE HANDLE. HE SAID IT DOES NOT WORK PROPERLY". 08.17.2020- UPDATED WITH FOLLOW-UP RESPONSE- DR STATED "I TRIED TO ABOUT 5 MINUTE TO REMOVE A RETAINED IUD WHICH I WAS NOT ABLE TO DO". 1216677-2020-00188 SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905102 SPOON FORCEPS LONG,SERRAT SPOON FORCEPS LONG,SERRAT HFB COOPERSURGICAL, INC. ES-LNGR NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other