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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. CERTUS PRECISION; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
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NEUWAVE MEDICAL, INC. CERTUS PRECISION; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES Back to Search Results
Catalog Number PR15 17GA
Device Problem Material Fragmentation (1261)
Patient Problem No Code Available (3191)
Event Date 02/16/2016
Event Type  malfunction  
Event Description
Two pr-15 probes under ultrasound guidance were advanced to the edge of the liver.Ablation began at 65 w and after a minute the team encountered an error with one of the probes.The team ensured the probe was in good position under ultrasound and attempted to ablate.They immediately encountered the error again.Ct was performed which demonstrated the tip of the probe had fragmented and there was air outside of the liver.The probe was removed and found to be fractured at the tip.
 
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Brand Name
CERTUS PRECISION
Type of Device
SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Manufacturer (Section D)
NEUWAVE MEDICAL, INC.
3529 anderson street
madison WI 53704
MDR Report Key5500461
MDR Text Key40363726
Report Number5500461
Device Sequence Number1
Product Code NEY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date09/01/2019
Device Catalogue NumberPR15 17GA
Device Lot NumberML15111744
Other Device ID NumberDR-000799
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2016
Event Location Hospital
Date Report to Manufacturer02/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age76 YR
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