MAUDE Adverse Event Report: COOPER SURGICAL/COOPERSURGICAL, INC. MARA WATER VAPOR ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Catalog Number	GEN-16-050
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Tissue Injury (4559); Pneumoperitoneum (4819)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent endometrial ablation with mara water vapor ablation system and was discharged home that same day.On (b)(6) 2023, she presented to the emergency department with complaints of severe abdominal pain.A ct scan showed pneumoperitoneum.She returned to the operating room at which time it was noted she had what appeared to be a thermal injury to her uterus and intestines.She underwent total hysterectomy, bilateral salpingectomy, ileocecectomy with primary anastomosis.

• Brand Name: MARA WATER VAPOR ABLATION SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): COOPER SURGICAL/COOPERSURGICAL, INC.; trumbull CT 06611
• MDR Report Key: 18118478
• Report Number: MW5148008
• Device Sequence Number: 6988622
• Product Code: MNB
• UDI-Device Identifier: 00857379006023
• UDI-Public: (01)00857379006023(11)210407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: GEN-16-050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic