BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 10839325 · Received November 13, 2020

    Report

    Report Number
    1216677-2020-00262
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 13, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT #2020-11-0000074 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 9/4/2019 UNDER WO #269843 AND SHIPPED ON 9/14/2019. MANUFACTURING RECORD REVIEW: DHR 269843 WAS 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 CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 95205, THIS UNIT WAS AT CSI ON 11/3/2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE. HOWEVER, UPON REMOVAL OF THE HOUSING THERE WAS 2 DAMAGED COMPONENTS ON THE DISPLAY BOARD. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE : AN INITIAL INVESTIGATION BY TECHNICAL OPERATIONS (CSI'S ENGINEERING DEPT.) HAS INDICATED RESISTORS R9 AND R14 WERE BURNT OUT DUE TO BEING EXPOSED TO CURRENT OUTSIDE THEIR RATING. THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO UNDER RATED RESISTORS. REF CAPA 731. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS FITTED WITH A NEW BOARD, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. CAPA 731 CULMINATED IN AN ENGINEERING UPDATE FOR THE COMPONENTS ON R9 & R14 AND VERIFIED UNDER ENG-TEST-10963. THE UPDATE WAS CAPTURED ON ECN-23707. NO FURTHER TRAINING REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    LEEP ALARM SOUNDING NO CUTTING/COAG. ORDER: 95205 FOLLOW UP FROM CUSTOMER: THERE WAS NO HOSPITAL STAY. THE PROCEDURE WAS EXTENDED DUE TO THE NEED TO COMPLETE MANUALLY. SHE WAS STABLE WHEN SHE LEFT. COMPLAINT VERIFIED. REF : E-COMPLAINT-2020-11-0000074 1216677-2020-00262 LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-2020-11-0000074.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    LEEP ALARM SOUNDING NO CUTTING/COAG. ORDER: 95205 FOLLOW UP FROM CUSTOMER: THERE WAS NO HOSPITAL STAY. THE PROCEDURE WAS EXTENDED DUE TO THE NEED TO COMPLETE MANUALLY. SHE WAS STABLE WHEN SHE LEFT. COMPLAINT VERIFIED. E-COMPLAINT-(B)(4). LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305818 LEEP PRECISION GENERATOR LEEP PRECISION HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other