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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number M00658001R0
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on (b)(6) 2014 for use in a hydrothermablation (hta) procedure.According to the complainant, the console failed the biomed electrical safety test and was rendered to be unusable.
 
Manufacturer Narrative
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.
 
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.No loose connections or loose or missing hardware were found.As the reported problem was not duplicated during the testing of the genesys console, the most probable root cause is not confirmed.Furthermore, this event is determined not to be mdr reportable.
 
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was being tested on (b)(6) 2014 for use in a hydrothermablation (hta) procedure.According to the complainant, the console failed the biomed electrical safety test and was rendered to be unusable.
 
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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 Key4327369
MDR Text Key5249049
Report Number3005099803-2014-03883
Device Sequence Number1
Product Code MNB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Model NumberM00658001R0
Device Catalogue Number58001R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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