BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 13009115 · Received December 15, 2021

    Report

    Report Number
    1216677-2021-00254
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    October 19, 2021
    Report Date
    February 28, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483 - DC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 02/24/2011 UNDER WO # 103423 AND SHIPPED ON 03-11-2011. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. 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 ON A REPAIR. 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. ROOT CAUSE: THE FOOT PEDAL IS USED TO ACTIVATE THE DEVICE. IF NOT FUNCTIONING THE POWER TO THE UNIT WILL NOT FLOW. THE FOOT PEDAL IS A MECHANICAL DEVICE AND HAS BEEN KNOWN TO FAIL AFTER EXTENDED USE. ROOT CAUSE IS BEING ATTRIBUTED TO WEAR AND TEAR ON THE FOOTPEDAL. CORRECTIVE ACTIONS : CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE DEFECTIVE FOOTPEDAL WAS REPLACED. THE DIAPHRAGM IN THE SWITCH WAS ALSO REPLACED AS A PRECAUTION TO PREVENT FURTHER ISSUES. A NEW DIAPHRAGM MADE FROM SILICONE WAS DESIGNED IN 2016. THE UNIT'S POWER OUTPUTS WERE ALSO ADJUSTED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 0

    POWER FOR CUTTING SHORTING OUT. ORDER: COMPLAINT VERIFIED: REPLACED FOOT PEDAL AND DIAPHRAGM. LEEP SYSTEM 1000 ESU GEN 52969, E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    POWER FOR CUTTING SHORTING OUT. ORDER: COMPLAINT VERIFIED: REPLACED FOOT PEDAL AND DIAPHRAGM.

    Description of Event or Problem · 0

    POWER FOR CUTTING SHORTING OUT. ORDER: COMPLAINT VERIFIED: REPLACED FOOT PEDAL AND DIAPHRAGM. LEEP SYSTEM 1000 ESU GEN (B)(4), E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905207 LEEP SYSTEM 1000 ESU GEN. LEEP SYSTEM 1000 ESU GEN. HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other