BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 19310638 · Received May 14, 2024

    Report

    Report Number
    1216677-2024-00022
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 27, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED FOR REPAIR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 12/26/2018 UNDER WO (B)(6) AND SHIPPED ON (B)(6) 2019. MANUFACTURING RECORD REVIEW: DHR'S 253855 & 253856 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. NONE OF THE OBSERVED NOTES INDICATE A SIMILAR ISSUE. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED AND PROCESSED UNDER LOG 101254 FOR UNCONFIRMED COMPLAINT AND SUBSEQUENTLY UPDATED TO THE LATEST REVISION 11/09/2023. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS IN REFERENCE TO "NOT CUTTING'. HOWEVER, THERE IS NO INDICATION THIS IS RELEVANT TO THIS COMPLAINT AS IT WAS FOUND TO FUNCTION FREE OF DEFECTS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED VIA (B)(4) AND AT CSI 5/31/2024. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE : THE DEVICE TESTED TO SPECIFICATION AND FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. A ROOT CAUSE IS NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE UNIT WAS EVALUATED, TESTED TO SPECIFICATIONS FREE OF DEFECTS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT HAD LOW POWER OUTPUT AND WOULD NOT CUT. NO PATIENT INJURY REPORTED. UNIT SENT FOR REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. LP-20-120 LEEP (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925451 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown