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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL CONSOLE WITH FOOTSWITCH; ULTRASONIC SURGICAL PRODUCTS
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INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL CONSOLE WITH FOOTSWITCH; ULTRASONIC SURGICAL PRODUCTS Back to Search Results
Catalog Number CUSAEXCEL9
Device Problem Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that the assy cable (207500643) on cusa excel console (product id cusaexcel9) had a burn mark on the ribbon cable connecting to the ultrasonic board and a burning smell occurred during use.There was no patient injury and delay in surgery is unknown.Additional information has been requested.
 
Event Description
N/a.
 
Manufacturer Narrative
Device history record: the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.Cusaexcel9 cusa excel console was returned for evaluation.Part: 207500643 assy cable mc us/40, burn mark in ribbon connecting ultrasonic board was found during inspection.Fault confirmed, cable was replaced during warranty.
 
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Brand Name
CUSA EXCEL CONSOLE WITH FOOTSWITCH
Type of Device
ULTRASONIC SURGICAL PRODUCTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES(IRELAND)
ida business&technology park
ida business&technology park
sragh, tullamore, co.offaly
EI 
MDR Report Key11594519
MDR Text Key244372224
Report Number3004608878-2021-00233
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
PMA/PMN Number
K981262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCUSAEXCEL9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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