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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. COOPER SURGICAL LEEP PRECISION INTEGRATED SYSTEM ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

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COOPERSURGICAL, INC. COOPER SURGICAL LEEP PRECISION INTEGRATED SYSTEM ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Model Number LP-010-120
Device Problems Use of Device Problem (1670); Defective Device (2588); Output Problem (3005)
Patient Problems Pain (1994); Distress (2329); Intermenstrual Bleeding (2665)
Event Date 03/23/2021
Event Type  Injury  
Event Description
Serious mental trauma; my gynecologist found abnormal cells on my cervix and performed a loop electrosurgical excision procedure (leep) on (b)(6) 2021 using a cooper surgical leep precision integrated system, model lp-010-120. Within hours of coming home after the procedure, i had heavy bleeding. I called my doctor and came back to her office the next day on (b)(6) 2021 for her to examine me. At this point, i was bleeding out significantly from my cervix, which was extremely scary and traumatizing. Using the same device, my doctor tried to re-cauterize the incisions she made to stop the bleeding. However, the cooper surgical device malfunctioned and was not working. Because the device malfunctioned, i ended up having to go the emergency room at mount sinai hospital where my doctor could use a different device to stop the bleeding. Ultimately, she was able to and i had to stay in the hospital for a day to fully recover before i could go home. The malfunctioning cooper surgical device caused me serious and significant blood loss - i had blood clots the size of my fist pouring out of me, massive trauma to my cervix - which took over one month to heal properly and could have resulted in serious, long term damage to my reproductive organs, and significant mental stress and trauma given the amount of blood loss, time in the hospital, and pain i had to withstand while my doctor tried to use the malfunctioning device. I understand from speaking with my doctor that she had the device serviced prior to my procedure. Clearly, it was not serviced properly. Since my procedure, i have received nearly (b)(6) in medical bills between my gynecologist and emergency treatment at (b)(6). This has been an extremely scary and life altering experience. Fda safety report id # (b)(4).
 
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Brand NameCOOPER SURGICAL LEEP PRECISION INTEGRATED SYSTEM
Type of DeviceELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
COOPERSURGICAL, INC.
MDR Report Key11893055
MDR Text Key253143820
Report NumberMW5101560
Device Sequence Number1
Product Code HGI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/24/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-010-120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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