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

Model Number	M006580211
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	10/15/2020
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, (b)(6) 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, the controller went from the cervical seal screen to releasing cassette.Circulator ejected the cassette and the staff opened a second device.Reportedly, the second device also malfunctioned during the sealing the test and was not heating up so the physician then decided to abort the case.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.
Event or Problem Description
It was reported to boston scientific corporation that genesys hta procerva procedure sets was used in a procedure performed on (b)(6) 2020.According to the complainant, the controller went from the cervical seal screen to releasing cassette.Circulator ejected the cassette and the staff opened a second device.Reportedly, the second device also mulfunctioned during the sealing the test and was not heating up so the physician then decided to abort the case.There were no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: device problem code 3191 is being used to capture the reportable issue of aborted/unknown procedure outcome.Evaluation conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 (b)(6) 2020.According to the complainant, the controller went from the cervical seal screen to releasing cassette.Circulator ejected the cassette and the staff opened a second device.Reportedly, the second device also mulfunctioned during the sealing the test and was not heating up so the physician then decided to abort the case.There were no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: device problem code 3191 is being used to capture the reportable issue of aborted/unknown procedure outcome.Evaluation conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.

• Brand Name: GENESYS HTA PROCERVA
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10793801
• Report Number: 3005099803-2020-05115
• Device Sequence Number: 16425532
• Product Code: MNB
• UDI-Device Identifier: 08714729809463
• UDI-Public: 08714729809463
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

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: M006580211
• Device Catalogue Number: 58021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/06/2020; 11/06/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/20/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1