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

Model Number	M006580010
Medical Device Problem Codes	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	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 october 1, 2020 that a genesys hta 115v control unit was used in a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a leak error message was received.Reportedly, there were no visible fluid leaks noted.The procedure was cancelled due to this event.There were no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code 3191 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h10: a symphion controller was returned for evaluation.Based on a thorough review of the complaint, the console was returned in overall good physical condition.The procedure sheath and cassette was not returned with the console.The console was tested as per cis - genesys hta functional feature test (b)(6).The reported complaint was not confirmed.The console passed all testing functional and electrical safety testing with no issues.Therefore, the most probable conclusion is no problem detected.The device displays error message could not be replicated during functional testing and no other fault conditions were identified during testing.The analysis of the available information in the complaint did not find any fault conditions within the product.The evidence from the product investigation review did not identify a potential product quality issue or new patient harm.It can be concluded that the consoler operates as intended with no issues.
Event or Problem Description
It was reported to boston scientific corporation on october 1, 2020 that a genesys hta 115v control unit was used in a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a leak error message was received.Reportedly, there were no visible fluid leaks noted.The procedure was cancelled due to this event.There were no patient complication 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: 10725712
• Report Number: 3005099803-2020-04721
• Device Sequence Number: 3180490
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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
• Device Lot Number: GEN1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1