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

Model Number	58001
Medical Device Problem Codes	Device Alarm System (1012); Device Displays Incorrect Message (2591); Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 08/12/2020.The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(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 that genesys hta 115v control unit was used in a procedure performed on an unknown date.According to the complainant, during hysteroscopy mode, the console went black without warning, rebooted itself as if the on and off switch had been pressed and rendered the cassette faulty.Reportedly, the plug being used had a piece of tape over it.However, the procedure was continued with the new cassette and during ablation mode a black smudge that grew quickly was noticed on the end of the scope.The physician did not have visualization of the cavity and went into override cooldown mode.The seal and placement were verified and initiated ablation mode.About two minutes into the procedure, the console showed an alarm of no flow and instructed to check for tissue obstruction and kinks in the tubing.The uterus had cramped down over the procedure sheath and several clots were present in the tubing, the physician identified this as the cause of the obstruction and decided to continue with the ablation.At about six minutes into the ablation, there was an alarm of fluid loss of 64cc/min.The bag of fluid was manually calculating a zero deficit for fluid loss.The physician decided to abort the procedure.There were no patient complication reported as a result of 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: 10501357
• Report Number: 3005099803-2020-03691
• Device Sequence Number: 14123246
• Product Code: MNB
• UDI-Device Identifier: 08714729809326
• UDI-Public: 08714729809326
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/08/2020

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: 58001
• Device Catalogue Number: 58001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1