BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION INTG. SYS.

    MDR report key: 14515185 · Received May 26, 2022

    Report

    Report Number
    1216677-2022-00159
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 10, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS INVESTIGATING THE REPORTED CONDITON.

    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 01/13/2015 UNDER WO#'S (B)(4) AND SHIPPED ON 04/27/2015. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) 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 NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE UNIT WAS RETURNED ON RMA #332262 ON 05/23/2022. VISUAL EVALUATION: COMPLAINT UNIT WAS IDENTIFIED AS A RECALL UNIT AND PROCESSED ACCORDINGLY. NO ADDITIONAL EVALUATION IS REQUIRED AS THE ISSUE HAS ALREADY IDENTIFIED THIS UNIT AS A POTENTIALLY AFFECTED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS IDENTIFIED AS A RECALL UNIT AND PROCESSED ACCORDINGLY. NO ADDITIONAL EVALUATION IS REQUIRED AS THE ISSUE HAS ALREADY IDENTIFIED THIS UNIT AS A POTENTIALLY AFFECTED UNIT. ROOT CAUSE: THE FAILURE MODE ON OTHER UNITS WAS DETERMINED TO BE DUE TO A LACK OF ISOLATION FROM THE CUT SIGNAL WHEN OPERATING THE COAG FUNCTION. THIS UNIT HAS BEEN IDENTIFIED AS A RECALL UNIT. PERTAINING TO THE COMPLAINT FOR BURNT LEG: THE UNIT WAS REPAIRED AND TESTED WITH NO INDICATION THE PATIENT PAD TESTING WAS SUSPECT. NO OTHER INFORMATION IS AVAILABLE BUT A POTENTIAL CONTRIBUTING FACTOR MAY LAY IN THE SET UP AT THE TIME OF USE OR HOW WELL THE PAD WAS SECURED TO THE PATIENT LEG. CORRECTIVE ACTIONS: THE UNITS' BOARD (P/N 300788-R) WAS UPDATED TO THE LATEST REVISION UNDER WO #(B)(4), TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. ADDITIONAL CORRECTIONS IN REGARD TO CAPA 744 WAS THE RELEASE OF ECN 24379, UPDATING A TEST PROCEDURE, RE-WORKING RELEVANT UNITS IN WIP AND RECALL 1216677-09-03-2021-003 WAS INITIATED. TRAIN PERSONNEL: WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    REPORT FORWARDED BY CUSTOMER SERVICE REPRESENTATIVE_ TRUMBULL. I GOT A CALL FROM SPRING HAYES AT EPHRAIM MCDOWELL REGIONAL MEDICAL CENTER, DANVILLE, KY. THEIR ACCOUNT NUMBER IS 380218. THEY HAVE THE LEEP PRECISION. THE UNIT IS NOT WORKING CORRECTLY AND TWO PATIENTS WERE BURNED. THE SERIAL NUMBER IS (B)(4). IT TURNS OUT THAT IS PART OF THE RECALL. 1216677-2022-00159 LEEP PRECISION INTG SYS LP-10-120 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    REPORT FORWARDED BY CUSTOMER SERVICE REPRESENTATIVE_ TRUMBULL. I GOT A CALL FROM (B)(6). THEIR ACCOUNT NUMBER IS (B)(6). THEY HAVE THE LEEP PRECISION. THE UNIT IS NOT WORKING CORRECTLY AND TWO PATIENTS WERE BURNED. THE SERIAL NUMBER IS (B)(6). IT TURNS OUT THAT IS PART OF THE RECALL. 1216677-2022-00159-1 LEEP PRECISION INTG SYS LP-10-120 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13067 LEEP PRECISION INTG. SYS. LEEP PRECISION INTG. SYS. HGI COOPERSURGICAL, INC. LP-10-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other