CORPATH 200 SYSTEM 160-00807

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for CORPATH 200 SYSTEM 160-00807 manufactured by Corindus, Inc..

Event Text Entries

[59458896] After investigation, corindus has repaired this unit during normal service activities.
Patient Sequence No: 1, Text Type: N, H10


[59458897] The customer reported that the articulated arm joints were loose and that the arm was moving freely. This issue occured prior to the procedure during setup and therefore did not have any patient involvement. Failure of the arm to hold position has the potential to result in unintended motion of the interventional devices if used on a patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007822508-2016-00002
MDR Report Key6076612
Date Received2016-11-03
Date of Report2016-11-03
Date of Event2014-10-10
Date Mfgr Received2015-10-22
Date Added to Maude2016-11-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROBERT LAVADO
Manufacturer Street309 WAVERLEY OAKS ROAD SUITE 105
Manufacturer CityWALTHAM MA 02452
Manufacturer CountryUS
Manufacturer Postal02452
Manufacturer Phone5086533335
Manufacturer G1CORINDUS, INC.
Manufacturer Street309 WAVELEY OAKS ROAD SUITE 105
Manufacturer CityWALTHAM MA 02452
Manufacturer CountryUS
Manufacturer Postal Code02452
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCORPATH 200 SYSTEM
Generic NameCORPATH 200 SYSTEM
Product CodeDXX
Date Received2016-11-03
Catalog Number160-00807
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCORINDUS, INC.
Manufacturer Address309 WAVERLEY OAKS ROAD SUITE 105 WALTHAM MA 02452 US 02452


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-03

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