MAUDE Adverse Event Report: BOSTON SCIENTIFIC GENESYS HTA PROCERVA; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Catalog Number M006580210

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/13/2015

Event Type  malfunction  

Event Description

Doctor was using device for endometrial ablation of uterine fibroids.About eight minutes into the ablation the machine shut off for fluid loss.The cervix was visualized and had no bleeding and no water noted.The machine was turned on and did not proceed, again stating fluid loss, and then a large gush of hot water was noted from the outer portion of the scope where the plastic connected onto the scope itself.Part of the plastic had broken off and hot water was leaking.The scope was immediately removed from the patient.Water was noted to have hit the patient's buttocks and perineum.She developed blistering where the water had reached her bare skin.The area was cleansed and silvadene cream applied.

• Brand Name: GENESYS HTA PROCERVA
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5180057
• MDR Text Key: 29322556
• Report Number: 5180057
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: M006580210
• Device Lot Number: 18285256
• Other Device ID Number: GTIN 08714729809456
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 133