BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION INTG. SYS.

    MDR report key: 13262870 · Received January 16, 2022

    Report

    Report Number
    1216677-2021-00320
    Event Type
    Malfunction
    Date Received
    January 16, 2022
    Date of Event
    December 20, 2021
    Report Date
    March 21, 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 CONDITON.

    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 01/08/2020 UNDER WO #'S (B)(4) AND SHIPPED ON 1/24/2020. MANUFACTURING RECORD REVIEW: DHR'S 269844 & 269837 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 UNIT WAS RETURNED ON RMA # (B)(4) 1/19/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. 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. CORRECTIVE ACTIONS THE UNITS' BOARD 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 (B)(4), UPDATING A TEST PROCEDURE, RE-WORKING RELEVANT UNITS IN WIP AND RECALL 1216677-09-03-2021-003 WAS INITIATED. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    "PATIENT WITH BLEEDING DUE TO FAILURE TO COAG". LEEP PRECISION INTG SYS LP-10-120 (B)(4).

    Description of Event or Problem · 0

    "PATIENT WITH BLEEDING DUE TO FAILURE TO COAG". LEEP PRECISION INTG SYS LP-10-120 (B)(4).

    Description of Event or Problem · 0

    "PATIENT WITH BLEEDING DUE TO FAILURE TO COAG". 1216677-2021-00320-1 LEEP PRECISION INTG SYS LP-10-120 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673967 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