BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOON FORCEPS LONG,SERRAT

    MDR report key: 12222971 · Received July 25, 2021

    Report

    Report Number
    1216677-2021-00148
    Event Type
    Malfunction
    Date Received
    July 25, 2021
    Date of Event
    July 6, 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
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED 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 IQC-20-08-20-11 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. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI REP ON BEHALF OF END-USER- "(B)(6) IS THE POINT OF CONTACT AND ORIGINATOR OF THIS COMPLAINT. I WAS NOTIFIED YESTERDAY 7/6/21. (B)(6) IS COPIED ON THIS E-MAIL. PROCEDURE DATE: (B)(6) 2021. PATIENT WAS INVOLVED, NOT HARMED, IUD RETRIEVAL WAS NOT SUCCESSFUL. ES-LNGR BROKE AT THE JAWS ON THE DISTAL END OF THE GRASPER WHILE DR LEWIS ATTEMPTED TO GRASP AND REMOVE AN IMPACTED IUD. PATIENT WILL NEED TO GO TO THE OPERATING ROOM FOR REMOVAL. COMPLAINT: (B)(4) LOT# 639458 BROKE AT THE JAW HINGE ON THE DISTAL END WHILE ATTEMPTING TO REMOVE AN IMPACTED IUD. DUE T THE BREAKAGE THE SURGEON WAS UNABLE TO CONTINUE TO ATTEMPT TO GRASP AND REMOVE THE IUD. 1216677-2021-00148 SPOON FORCEPS LONG SERRAT ES-LNGR E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI REP ON BEHALF OF END-USER- "(B)(6)IS THE POINT OF CONTACT AND ORIGINATOR OF THIS COMPLAINT. I WAS NOTIFIED YESTERDAY 7/6/21. (B)(6) IS COPIED ON THIS E-MAIL. PROCEDURE DATE: (B)(6) 2021. PATIENT WAS INVOLVED, NOT HARMED, IUD RETRIEVAL WAS NOT SUCCESSFUL. ES-LNGR BROKE AT THE JAWS ON THE DISTAL END OF THE GRASPER WHILE DR LEWIS ATTEMPTED TO GRASP AND REMOVE AN IMPACTED IUD. PATIENT WILL NEED TO GO TO THE OPERATING ROOM FOR REMOVAL. COMPLAINT: ES-LNGR LOT# 639458 BROKE AT THE JAW HINGE ON THE DISTAL END WHILE ATTEMPTING TO REMOVE AN IMPACTED IUD. DUE T THE BREAKAGE THE SURGEON WAS UNABLE TO CONTINUE TO ATTEMPT TO GRASP AND REMOVE THE IUD. SPOON FORCEPS LONG SERRAT ES-LNGR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119795 SPOON FORCEPS LONG,SERRAT SPOON FORCEPS LONG,SERRAT HFB COOPERSURGICAL, INC. ES-LNGR 639458

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other