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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM
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CORINDUS, INC. CORPATH GRX SYSTEM Back to Search Results
Model Number 302
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
A loose extended reach arm has the potential to cause unintended motion of the interventional devices.It was not reported if this unit was used on a patient in this condition, however no patient complications and no unintended movement of interventional devices has been reported by the facility.Corindus service has evaluated the unit and determined that the friction joint of the extended reach arm had loosened beyond specification.Service was conducted to the friction joint to return the extended reach arm to specification.
 
Event Description
The user noted that the friction joint of the extended reach arm was loose.
 
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Brand Name
CORPATH GRX SYSTEM
Type of Device
CORPATH GRX SYSTEM
Manufacturer (Section G)
CORINDUS, INC.
309 waverley oaks road
suite 105
waltham MA 02452
Manufacturer Contact
robert lavado
309 waverley oaks road
suite 105
waltham, MA 02452
5086533335
MDR Report Key8767829
MDR Text Key213485527
Report Number3007822508-2019-00005
Device Sequence Number1
Product Code DXX
UDI-Device Identifier00816280023024
UDI-Public(01)00816280023024(11)171128
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number302
Device Catalogue Number302
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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