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

Catalog Number C7000

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident was not yet received for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A sales representative reported on behalf of the customer that on (b)(6) 2018, a c7000 cusa clarity was used during a left temporal lobectomy.The surgeon was stepping on the orange footswitch but there was no power to the tip.The amplitude column on the screen did not light up.There was also no reaction from the blue pedal.Additional information was received on (b)(6) 2018 stating that the device was in contact with the patient.There was surgery delay due to product problem.According to the sales representative, the delay in the case was hard to tell.If the clarity had been working properly, it could have improved the overall case time significantly, even hours.There were several delays while the staff had to retrieve and set-up different equipment.The case was completed with a different device.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.One of the footswitch pin receptacles was pushed in and prevented the consistent contact.Also, one of the pin connector was damaged.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The complaint was verified.The cause of the complaint incident could not be identified.

• 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: 7697745
• MDR Text Key: 114428003
• Report Number: 3006697299-2018-00038
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1