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

Model Number	74060
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: a genesys hta capital was returned in good condition with no physical damages/defects observed.The unit failed at step 3.0 of cis-genesys hta functional feature test.The screen display system error 38 was observed during the test.The hta error code dictionary indicated disposable pca defected.A disposable pca with known good condition was installed and power on the console.The console completed boot up no system error 38.The reported problem was confirmed.Review and analysis of all available information indicated that the failure was determined to be a defective disposable pca in the right enclosure assembly of the unit.It could not be determined what caused the disposable pca to become defective.Therefore the most probable root cause is cause trace to component failure.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hta capital was used in a hysteroscopic thermal ablation (hta) procedure in the uterus performed on (b)(6), 2018.According to the complainant, during the procedure, the device was giving error 38, a power related issue.The device was unplugged and plugged back into a different source but still the error persist.The procedure was cancelled due to this event.There were no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Device problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Investigation results: genesys hta capital was returned in good condition with no observable physical damages/defects.During functional testing, "system error 38" was observed indicating a disposable printed circuit array (pca)defect.The disposable pca was replaced and the console was retested.The console powered on with no issues.Based on the issue identified during the functional testing, the reported problem of "system error 38" was confirmed.It could not be determined what caused the disposable pca to become defective therefore, the most probable root cause is "cause trace to component failure".A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hta capital was used in a hysteroscopic thermal ablation (hta) procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, the device was giving error 38, a power related issue.The device was unplugged and plugged back into a different source but still the error persist.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: 9163002
• Report Number: 3005099803-2019-04926
• Device Sequence Number: 16658465
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: 08714729809357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/10/2019

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: 74060
• Device Catalogue Number: 74060
• Device Lot Number: GEN1568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1