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

Model Number M00658001R0

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

(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 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 performed on (b)(6) 2019.According to the complainant, during the procedure, the console rebooted without any buttons pressed and error massages press del to run and usb mass storage auto detecting appeared on the screen.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
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9218969
• MDR Text Key: 178740735
• Report Number: 3005099803-2019-05161
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: 08714729809357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00658001R0
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR