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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE
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INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE Back to Search Results
Catalog Number C7000
Device Problems Device Alarm System (1012); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
It was reported that the aspiration was set at 100% on the c7000 cusa clarity console.However, it was found that the aspiration was 50.794mmhg when troubleshooting was carried.The customer reported that the device did not give any alarm signal.
 
Manufacturer Narrative
(b)(4).The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - evaluation verified customer information as valid.Broken elbow has to be exchanged.Root cause - confirmed.Broken suction elbow.
 
Event Description
N/a.
 
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Brand Name
CUSA CLARITY CONSOLE
Type of Device
CUSA CLARITY
Manufacturer (Section D)
INTEGRA LIFESCIENCES(IRELAND)
ida business&technology park
ida business&technology park
sragh, tullamore, co.offaly
EI 
MDR Report Key10466151
MDR Text Key206761029
Report Number3006697299-2020-00099
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
PMA/PMN Number
K161882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC7000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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