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

Model Number	58001R
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2016
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on (b)(6) 2016.According to the complainant, the console skipped a procedural step at the seal integrity check phase, went to cool down mode and registered an ¿insufficient patient cooling message.¿.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on (b)(6), 2016.According to the complainant, the console skipped a procedural step at the seal integrity check phase, went to cool down mode and registered an insufficient patient cooling message.
Additional Manufacturer Narrative
Investigation results: the genysys hta controller was received in good condition.Visual examination revealed no damages or defects and the procedure set used was not returned for evaluation.Functional analysis was performed which revealed no skipping of the procedural step and the unit passed the genesys hta functional feature test.During seal integrity check, the temperature was in ambient temperature.The hta controller went into cool down while conducting a seal integrity check only when cassette thermistor malfunction reading temperature over 94 degree celsius.Therefore, a review and analysis of all available information indicated that the root cause is no problem detected.A complaint with a cause of no problem detected indicates that the device complaint or problem cannot be confirmed.

• Brand Name: GENESYS HTA SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; north dock; marlborough MA 01752
• MDR Report Key: 6123058
• Report Number: 3005099803-2016-03571
• Device Sequence Number: 1129301
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: (01)08714729809357(11)20130426
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: Other
• Device Model Number: 58001R
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1