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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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BOSTON SCIENTIFIC CORPORATION ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 8864
Device Problem No Display/Image (1183)
Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Event Date 07/23/2020
Event Type  malfunction  
Event Description
It was reported that a cancelled procedure occurred.A polaris mmg system was selected for use.During procedure, it was noted that the unit is experiencing image issues.The procedure was not completed due to this event.No patient complications were reported.
 
Manufacturer Narrative
The acquisition processor was returned with software that was not compatible with the current system; therefore, functional testing could not be performed.
 
Event Description
It was reported that a cancelled procedure occurred.A polaris mmg system was selected for use.During procedure, it was noted that the unit is experiencing image issues.The procedure was not completed due to this event.No patient complications were reported.
 
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Brand Name
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10417228
MDR Text Key203295162
Report Number2134265-2020-11133
Device Sequence Number1
Product Code DQK
UDI-Device Identifier08714729946106
UDI-Public08714729946106
Combination Product (y/n)N
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8864
Device Catalogue Number8864
Device Lot Number0000201261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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