MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number M006580010

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on an unknown date.According to the complainant, the console failed the biomed ground safety test and was rendered to be unusable.

Manufacturer Narrative

Analysis of the returned genesys hydrothermal ablation (hta) endometrial ablation system revealed that the unit passed the functional test.The console was inspected and no visible damage or defects was observed.The power cord was not returned for evaluation analysis of the returned device showed no evidence of the alleged issue or any other defect, therefore; the most probable root cause is not confirmed.A review of the device history record (dhr) was performed; no anomalies were noted.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermal ablation endometrial ablation system was being tested on an unknown date.According to the complainant, the console failed the biomed ground safety test and was rendered to be unusable.

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5668486
• MDR Text Key: 45572843
• Report Number: 3005099803-2016-01378
• Device Sequence Number: 1
• Product Code: MNB
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006580010
• Device Catalogue Number: 58001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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