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

Model Number	M006580211
Medical Device Problem Codes	Filling Problem (1233); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; 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 physician could not get a seal after doing a resector case on the same patient.It was suspected that there was over dilation of cervix with scope prior to hta case.Reportedly, no error message appeared on the console, it just could not seal the cervix.The integrity check would not allow them to proceed.The physician then decided to abort the procedure following the issue with the device.There were no patient complication reported as a result of this event.

• 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: 10799988
• Report Number: 3005099803-2020-05164
• Device Sequence Number: 11579955
• Product Code: MNB
• UDI-Device Identifier: 08714729809463
• UDI-Public: 08714729809463
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/06/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1