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

Model Number	M00658001R0
Medical Device Problem Codes	Failure to Power Up (1476); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a genesys hta control unit was used in a hydrothermal ablation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the console rebooted without any buttons pressed and error massages press del to run and usb mass storage auto detecting appeared on the screen.The procedure was cancelled due to this event.There were no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: GENESYS HTA SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9218969
• Report Number: 3005099803-2019-05161
• Device Sequence Number: 2734384
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: 08714729809357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/22/2019

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): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR