MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE

Catalog Number C7000

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be 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.Linked to mfg report number 3006697299-2020-00076.

Event Description

This is 1 of 2 reports.A customer reported that the touch screen of the c7000 cusa clarity console loss its control in a certain manner.It went to run mode from standby mode by itself when they randomly pressed the button on the screen and the setting in run mode could not be adjusted.When the customer moved the control scale values, it fluctuated and could not sense the user's finger movement.They tried to move the system console away from the electrosurgical generator about 2.5 meters and the problem was improved but could not be resolved.There was no error ,message noted.The surgeon once tried to activate and test both cem nosecone and cusa in the air and both of them worked but when used it on the patient, it goes to standby mode by itself.The malfunction was noted during a liver resection on (b)(6) 2020.The patient was prepped for the procedure.There was an hour delay noted with no adverse consequence to the patient.The procedure was completed by replacing the unit with a cusa excel system.The patient was fine after the procedure.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6, h10.Device identifier: (b)(4).Product identifier: (b)(4).The device was not returned for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.The device history record (dhr) documentation was reviewed and showed no abnormalities related to the reported failure.The reported complaint was not confirmed.Additional information received stated that the device will not be returned for evaluation and the unit was used for two more trials on (b)(6)2020.The unit functioned normally on those trials.

• 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 Key: 10221492
• MDR Text Key: 214800783
• Report Number: 3006697299-2020-00075
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K161882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1