MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	M00658001R0
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2016.According to the complainant, during hysteroscopy phase, the physician wanted to perform additional hysterocopy but the machine went directly to seal integrity check phase without touching or pressing the control buttons.The procedure was completed using the same console.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be doing well.

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 6172631
• Report Number: 3005099803-2016-03913
• Device Sequence Number: 19186980
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: (01)08714729809357(11)20120214
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P000040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00658001R0
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1