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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GENESYS HTA SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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BOSTON SCIENTIFIC CORPORATION GENESYS HTA SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number M006580010
Medical Device Problem Codes No Display/Image (1183); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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 on (b)(6) 2019 that a genesys hta control unit was used in a hydrothermal ablation procedure performed on (b)(6) 2019.According to the complainant, during preparation, the screen of the console was blank.The unit was rebooted but the issue persist.The procedure was cancelled due to this event.
 
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Brand Name
GENESYS HTA SYSTEM
Common Device Name
DEVICE, THERMAL ABLATION, ENDOMETRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9250784
Report Number3005099803-2019-05168
Device Sequence Number19358977
Product Code MNB
UDI-Device Identifier08714729809326
UDI-Public08714729809326
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P000040
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/29/2019
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 NumberM006580010
Device Catalogue Number58001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/17/2019
Initial Report FDA Received Date10/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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