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

Model Number M006580211

Device Problems Filling Problem (1233); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

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 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
• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10799988
• MDR Text Key: 225871546
• Report Number: 3005099803-2020-05164
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809463
• UDI-Public: 08714729809463
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006580211
• Device Catalogue Number: 58021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1