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

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).

• Brand Name: COOPER SURGICAL LEEP PRECISION INTEGRATED SYSTEM
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 11893055
• MDR Text Key: 253143820
• Report Number: MW5101560
• Device Sequence Number: 1
• Product Code: HGI
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP-010-120
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 72