MAUDE Adverse Event Report: BOSTON SCIENTIFIC GENISYS HTA PROCERVA; HTA ABLATION

Model Number M006580211

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 02/01/2017

Event Type  Injury  

Event Description

Vaginal thermal injury during procedure; pt was having a uterine ablation procedure in the operating room using the hta genisys system.Hot fluid leaked into vaginal vault causing burn.

• Brand Name: GENISYS HTA PROCERVA
• Type of Device: HTA ABLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC ; natick MA 01760
• MDR Report Key: 6439146
• MDR Text Key: 71162509
• Report Number: MW5068700
• Device Sequence Number: 1
• Product Code: MNB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M006580211
• Device Lot Number: 08714729809456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 101