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

Model Number	M006580010
Medical Device Problem Codes	Device Alarm System (1012); Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No event date was given, therefore an approximate date of (b)(6) 2019 was used as the event date.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 on (b)(6) 2019 that a genesys hta control unit was used in a hydrothermal ablation procedure in the uterus performed on an unknown date.According to the complainant, during procedure, a fluid leak alarm was noted on the console.A second cassette was used and error message 11 appeared on the screen.The procedure was cancelled due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Investigation results: a genesys hta capital was returned for investigation.The device was received in fair condition with no physical damages or defects observed.The unit passed cis-genesys hta functional feature test.Fluid leak alarm or error 11 was not observed during the test thereby not confirming the event.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.A dhr (device history record) review was performed and the device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation on october 9, 2019 that a genesys hta control unit was used in a hydrothermal ablation procedure in the uterus performed on an unknown date.According to the complainant, during procedure, a fluid leak alarm was noted on the console.A second cassette was used and error message 11 appeared on the screen.The procedure was cancelled due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9281259
• Report Number: 3005099803-2019-05405
• Device Sequence Number: 14084446
• Product Code: MNB
• UDI-Device Identifier: 08714729809326
• UDI-Public: 08714729809326
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: M006580010
• Device Catalogue Number: 58001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1