BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 9819834 · Received March 11, 2020

    Report

    Report Number
    1216677-2020-00078
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 5, 2020
    Report Date
    May 26, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483DISCO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS. (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 8/26/2009 UNDER WO (B)(4) AND SHIPPED ON 8/28/2009. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THIS TIME. HOWEVER, AT THE TIME OF MANUFACTURE, RECORDS FROM EACH UNIT ARE REVIEWED TO ENSURE THAT PRODUCT MEET ALL SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED, THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: N/A . SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED UNDER LOG 88406 ON 3/14/20018 FOR A FAULTY INTERNAL SWITCH OR THE DIAPHRAGM. NO OTHER RECORD FOR THIS UNIT EXISTS BEFORE 2018. THIS WAS ADDRESSED AND HAS NO RELEVANCE TO THIS COMPLAINT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 93792, THIS UNIT WAS AT CSI ON 1/31/2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: UNIT WAS NOT FUNCTIONING PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION: THE REPAIR AUTHORIZATION FORM SPECIFICALLY NOTES THE UNIT WAS CHECKED OUT BY THE CUSTOMER AND FOUND TO BE IN WORKING ORDER. A REQUEST TO HAVE THIS UNIT CHECKED BY CSI WAS MADE BY THE CUSTOMER. THIS UNIT WAS CONFIRMED TO OPERATE TO SPECIFICATIONS AT CSI AS WELL AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    INITIALLY, I USED A 2.O LOOP FOR THE PROCEDURE AND THE SETTING WAS 58; IT WAS WITH THAT INITIAL CUT THAT THE COPIOUS BLEEDING TO THE CERVIX WAS NOTED. AS A TOP-HAT, I USED A 1.O LOOP AND IT WAS SET ON 60 HOWEVER THAT CUT DID NOT HAVE MORE BLEEDING THAN USUAL. THE ROLLERBALL SETTING WAS 60 WATTS HOWEVER THAT IS THE SETTING THAT IS RECOMMENDED ON THE ATTACHMENT ON THE MACHINE AT RENAISSANCE FOR THE ROLLERBALL. THE COPIOUS AMOUNT OF BLEEDING STARTED WITH THE 2 CM LOOP. NOT THE 1 CM TOP-HAT LOOP. (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    INITIALLY, I USED A 2.O LOOP FOR THE PROCEDURE AND THE SETTING WAS 58; IT WAS WITH THAT INITIAL CUT THAT THE COPIOUS BLEEDING TO THE CERVIX WAS NOTED. AS A TOP-HAT, I USED A 1.O LOOP AND IT WAS SET ON 60 HOWEVER THAT CUT DID NOT HAVE MORE BLEEDING THAN USUAL. THE ROLLERBALL SETTING WAS 60 WATTS HOWEVER THAT IS THE SETTING THAT IS RECOMMENDED ON THE ATTACHMENT ON THE MACHINE AT RENAISSANCE FOR THE ROLLERBALL. THE COPIOUS AMOUNT OF BLEEDING STARTED WITH THE 2 CM LOOP. NOT THE 1 CM TOP-HAT LOOP. E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285220 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