BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR 120VAC

    MDR report key: 18874167 · Received March 11, 2024

    Report

    Report Number
    1216677-2024-00010
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 11, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED FOR REPAIR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 28-JUL-2016 UNDER WORK ORDER (B)(4) AND SOLD ON 01-SEP-2016 AS PART OF A LP-10-120 SYSTEM. MANUFACTURING RECORD REVIEW: DHR-192638 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 96425- 01-JUN-2021- HANDPIECE NOT WORKING- NEEDED RECALL UPDATE. 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 AND AT CSI ON 20-FEB-2024. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ONE OBSERVATION WAS NOTED WHERE THE RF LEAKAGE WAS OUT OF SPECIFICATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NOTE: THE COAG FUNCTION REQUIRES THE SITE TO HAVE THE LEAST AMOUNT OF BLOOD PRESENT WHEN IN USE. THE INFORMATION PROVIDED CONFIRMED AN UNUSUAL QUANTITY OF BLOOD WAS PRESENT WHICH CAN IMPACT THE COAG FUNCTION. THE UNIT WAS ADJUSTED TO THE APPROPRIATE RF RANGE, TESTED TO SPECIFICATION, AND RETURNED TO THE CUSTOMER. NO ADDITIONAL ACTIONS WERE REQUIRED TO CORRECT THE ISSUE ON THIS UNIT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NOTE: ALTHOUGH THE RF SETTING WAS OUT OF TOLERANCE REQUIRING AN ADJUSTMENT OF R77 TO MEET THE SPECIFICATION FOR THIS SETTING, IT WAS NOT RELATED TO THE ISSUE NOTED IN THIS COMPLAINT. THE UNIT WAS FOUND TO FUNCTION FREE OF DEFECTS AND THE COMPLAINT IS DEEMED AS NOT CONFIRMED FOR A FUNCTIONAL ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LOOP ELECTROSURGICAL EXCISION PROCEDURE OF THE CERVIX ON (B)(6) 2024, THE CAUTERY FUNCTION OF THE DEVICE WAS NOT WORKING. PROCEDURE WAS COMPLETED WITH ANOTHER CAUTERY MACHINE FROM THE OUT-PATIENT SURGERY CENTER. GREATER THAN NORMAL BLEEDING. NO ADDITIONAL INFORMATION AVAILABLE. 1216677-2024-00010, LP-20-120 LEEP, 2024-02-0000533.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450417 LEEP PRECISION GENERATOR 120VAC ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female