BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION INTEGRATED SYSTEM

    MDR report key: 21752114 · Received April 2, 2025

    Report

    Report Number
    1216677-2025-00014
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 28, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014228
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/18/2021 AND SHIPPED ON 10/26/2021. MANUFACTURING RECORD REVIEW: DHR'S 310577 & 296641 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: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DOES NOT REVEAL SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE UNIT WAS NOT RETURNED. VISUAL EVALUATION: A VISUAL EVALUATION COULD NOT BE COMPLETED AS THE COMPLAINT UNIT WAS NOT REQUIRED TO BE RETURNED TO COOPERSURGICAL. FUNCTIONAL EVALUATION: A FUNCTIONAL EVALUATION COULD NOT BE COMPLETED AS THE COMPLAINT UNIT WAS NOT REQUIRED TO BE RETURNED TO COOPERSURGICAL. ROOT CAUSE: THE INFORMATION ON THE COMPLAINT AND A DISCUSSION WITH SERVICE & REPAIR INDICATES THE CUSTOMER HAD NOT USED A WALL OUTLET AND LIKELY HAD NOT HAD THE GENERATOR FULLY SEATED IN CART. THE POWER TO THE GENERATOR COMES FROM CONNECTING TO THE INTERNAL CONNECTOR IN THE CART SLOT. ALSO, THE UNIT MUST BE POWERED FROM A WALL OUTLET PER THE IFU. THIS IS ATTRIBUTABLE TO END USER ERROR.

    Additional Manufacturer Narrative · 0

    DEVICE IS FUNCTIONING PROPERLY PER CUSTOMER AND IS NOT BEING RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025, THAT THE LEEP WAS SHUTTING OFF WHEN USING THE COAGULATION BUTTON. UPON CONSULTATION WITH CSI EMPLOYEE, IT WAS DETERMINED THAT THE LEEP MACHINE WAS NOT CONNECTED TO A WALL OUTLET DURING THE PROCEDURE AND THE CONNECTION TO THE MACHINE WAS LOOSE. CUSTOMER WAS ABLE TO FIGURE OUT WHAT THE PROBLEM WAS, AND THE MACHINE IS NOW WORKING PROPERLY. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION PROVIDED. 1216677-2025-00014 LP-10-120 LEEP 2025-03-0000333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745627 LEEP PRECISION INTEGRATED SYSTEM ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-10-120 00888937014228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown