BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION

    MDR report key: 14138188 · Received April 18, 2022

    Report

    Report Number
    1216677-2022-00113
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 22, 2022
    Report Date
    May 27, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 01/28/2021 UNDER WO#'S (B)(4) & (B)(4) AND SHIPPED ON 02/21/2021. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) & (B)(4) WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS REPAIRED UNDER A RE-WORK WORK ORDER (B)(4) JANUARY 2022 AND RETURNED FEBRUARY 2022. THE REPAIR IS UNRELATED TO THE COMPLAINT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 98250, THIS UNIT WAS AT CSI ON 4/12/2022. 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. THE UNIT FAILED THE RF LEAKAGE TEST SECTION FOR COAG OF THE STANDARD IN-PROCESS TESTING. ROOT CAUSE: A ROOT CAUSE FOR THE COMPLAINT CONDITION IS NOT DEFINITIVELY DETERMINED. THE COAG FUNCTION IS KNOWN REQUIRE A SITE THAT HAS MINIMAL BLOOD PRESENT AND MAY NOT WORK WELL IN AN EXCESSIVELY WET ENVIRONMENT. IT IS NOT CLEAR IF THE LEAKAGE ERROR DETECTED IS A SOLE CONTRIBUTING FACTOR OR IF THE EXCESSIVE BLEEDING NOTED WAS A EQUAL OR GREATER CONTRIBUTOR TO THE COMPLAINT CONDITION. BASED ON THE INFORMATION AVAILABLE THIS FINDING SUGGESTS A POTENTIAL FOR A DESIGN RELATED ISSUE BEST EVALUATED BY TECH OPS. *CORRECTION AND/OR CORRECTIVE ACTION. THE UNIT WAS FITTED WITH A NEW BOARD, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE MAIN BOARD PULLED OUT (S/N (B)(6)) WAS SET ASIDE FOR FURTHER EVALUATION BY THE TECH OPS EE UNDER PROJECT #(B)(4). COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    COMPLAINT INFORMATION PROVIDED BY CSI SALES: "PENCIL PROBLEM- ON (B)(6) 2022, DR. (B)(6): 28 YO FEMALE HGSIL (CIN II) FISCHER SURGICAL CONE BIOPSY GYNEX BALL ELECTRODE EXCESSIVE BLEEDING/UNABLE. PROVIDER USED THE CUT SETTING TO MAKE THE INITIAL INCISION. DR. (B)(6) DID SWITCH TO BLEND AFTER SHE NOTICED AN ISSUE WITH BLEEDING. PROVIDER USE A 50:50 MIX OF LIDOCAINE 1% AND LIDOCAINE WITH EPI FOR CERVICAL BLOCKS TO HELP MANAGE BLEEDING. PATIENTS REQUIRED MEDICAL ATTENTION WITH PACKING AND LYING DOWN UNTIL BLEEDING COULD BE CONTROLLED. ON (B)(6) 2022- UPDATED WITH REPAIR LOG # 98250- PER SERVICE & REPAIR TEAM- RECEIVED LEEP PRECISION HERE ON DUAL COMPLAINT FOR EXCESSIVE BLEEDING. IT IS ON REPAIR LOG 98250. EMERGENCY DEPARTMENT DID A FULL TEST AND FINDS THE RF LEAKAGE FOR COAG IS OUT OF SPEC. NO OTHER ISSUES. LEEP PRECISION INTG SYS LP-10-120 (B)(4).

    Description of Event or Problem · 0

    COMPLAINT INFORMATION PROVIDED BY CSI SALES- "PENCIL PROBLEM-3/22/2022-DR. (B)(6) (B)(6) - 28 YO FEMALE HGSIL (CIN II) FISCHER SURGICAL CONE BIOPSY GYNEX BALL ELECTRODE_ EXCESSIVE BLEEDING/UNABLE. PROVIDER USED THE CUT SETTING TO MAKE THE INITIAL INCISION. DR. MCCARREL DID SWITCH TO BLEND AFTER SHE NOTICED AN ISSUE WITH BLEEDING. PROVIDER USE A 50:50 MIX OF LIDOCAINE 1% AND LIDOCAINE WITH EPI FOR CERVICAL BLOCKS TO HELP MANAGE BLEEDING. PATIENTS REQUIRED MEDICAL ATTENTION WITH PACKING AND LYING DOWN UNTIL BLEEDING COULD BE CONTROLLED. 04/13/2022- UPDATED WITH REPAIR LOG # 98250- PER SERVICE & REPAIR TEAM- RECEIVED LEEP PRECISION HERE ON DUAL COMPLAINT FOR EXCESSIVE BLEEDING. IT IS ON REPAIR LOG 98250. ED DID A FULL TEST AND FINDS THE RF LEAKAGE FOR COAG IS OUT OF SPEC. NO OTHER ISSUES. 1216677-2022-00113 LEEP PRECISION INTG SYS LP-10-120 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52436 LEEP PRECISION LEEP PRECISION HGI COOPERSURGICAL, INC. LP-10-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other