Model Number M00658001R0 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2014 |
Event Type
malfunction
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Event Description
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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 did not pass the biomed leak test, it failed customer safety test and was rendered to be unusable.
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Manufacturer Narrative
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The device has been received for analysis.Upon 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.
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Manufacturer Narrative
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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.
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Event Description
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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 did not pass the biomed leak test, it failed customer safety test and was rendered to be unusable.
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Search Alerts/Recalls
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