BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 15258044 · Received August 19, 2022

    Report

    Report Number
    1216677-2022-00228
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    August 1, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR: INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: COMPLAINT: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/05/2015 UNDER WO#'S (B)(4). MANUFACTURING RECORD REVIEW: DHR'S 182215 & 182194 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED VIA RMA 334565 ON 8/9/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT HAD RF LEAKAGE. ROOT CAUSE: CAPA: 801 WAS INITIATED TO DETERMINE A ROOT CAUSE. ALTHOUGH NOT FINALIZED, THE INVESTIGATION HAS DETERMINED THE DESIGN IS INTACT AND NOT FAULTY. THE LEEP SYSTEM IS DESIGNED WITH A SAFETY FEATURE TO CUT POWER IN ANY MODE WHEN RF LEAKAGE IS DETECTED. THIS IS IN PLACE TO PROTECT THE END USER AND PATIENT FROM POTENTIAL SHOCK. IN THE INVESTIGATION THE FAILURE HAD BEEN REPEATED UNDER CERTAIN CONDITIONS SUPPORTING THIS ISSUE IS LIKELY DUE TO UNIQUE CONDITIONS IN THE FIELD REGARDING SET UP AND PLACEMENT OF CHORDS. CORRECTIVE ACTIONS: THE UNIT WAS FITTED WITH A NEW BOARD AND FURTHER PROCESSED, INCLUDING TESTING, THROUGH A RECALL REPAIR PROCESS NOT RELATED TO THIS COMPLAINT CONDITION. THE PROCESS IS SET UP TO RETURN DIRECTLY TO THE CUSTOMER. ALL PRODUCT WAS PLACED ON HOLD AND LATER RELEASED PER AN EVALUATION OF THE FINDINGS ON THE CAPA INVESTIGATION TO BE FORMALLY COMPLETED NOVEMBER 2022. THE INVESTIGATION PORTION OF THE CAPA PROCESS WILL BE CONSIDERED COMPLETE BUT THE IMPLEMENTATION PORTION WILL CONTINUE WITH SOME ACTIONS BASED ON THE INVESTIGATION. NO FURTHER TRAINING REQUIRED. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    NOT CUTTING OR COAGULATING. FS LOG#: 98946. LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-2022-08-0000263.

    Description of Event or Problem · 0

    NOT CUTTING OR COAGULATING. FS LOG#: (B)(4). 1216677-2022-00228-1 LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816178 LEEP PRECISION GENERATOR LEEP PRECISION GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other