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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION URONAV; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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INVIVO CORPORATION URONAV; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
Case canceled in or (operating room), after administration of anesthesia due to uronav equipment failure.Uronav equipment had a hardware repair/replacement service last week, the system was tested by uronav service tech and said to be working fine.Patient brought to operating room, uronav system unable to connect to dynacad system to pull patient¿s mri for case.Ultrasound tech working with uronav tech support.Uronav tech support figured out a work around to connect to dynccad.Patient sedated with anesthesia for procedure and uronav system unable to connect.Manufacturer response for uronav, invivo (per site reporter).They have determined that the dvi port is corrupted, and they are going to fix it.
 
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Brand Name
URONAV
Type of Device
SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
INVIVO CORPORATION
12151 research pkwy
orlando FL 32826
MDR Report Key12951487
MDR Text Key281847418
Report Number12951487
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2021,11/30/2021
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
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2021
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer12/07/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21170 DA
Patient SexMale
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