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

Model Number M00658001R0

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Uid=( (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 (b)(6) 2016.According to the complainant, the console did not pass the biomed electrical safety test and was rendered to be unusable.

Manufacturer Narrative

Analysis of the returned genesys hydrothermablation (hta) endometrial ablation system revealed that the unit passed the leakage & earth resistance safety test and ac current draw test.The console was opened and visually inspected for loose connections and loose or missing hardware.It was observed that the power entry module mounting bracket insert was separated from the rear enclosure assembly, most probably excessive physical force was applied to the ac power entry module causing the rear enclosure assembly to become separated that could have contributed to the reported failure.Therefore, the most probable root cause is handling damage.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on (b)(6) 2016.According to the complainant, the console did not pass the biomed electrical 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: 5446008
• MDR Text Key: 38530377
• Report Number: 3005099803-2016-00330
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M00658001R0
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2013
• 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