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

Catalog Number	C7000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3006697299-2024-00136: a facility reported that a system error message occurred on cusa clarity console (c7000) prior to surgery.It was rebooted, but it could not be used, and another device was used to complete the surgery.Surgical delay was more than 30 minutes.The following day, a company representative visited the facility to check the device, and re-installed the software which resolved the issue.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa clarity console (c7000) was evaluated: device history record (dhr) - the dhr was reviewed, and no anomalies were observed during manufacture or packaging that could be associated with the complaint incident.Failure analysis - the investigation of the unit confirmed the complaint: an integra field service engineer (fse) visited the facility and evaluated the device.The fse was unable to duplicate the reported issue but was able to confirm the system error in the unit's log files.To resolve the issue, the fse re-installed the software, checked the start up with the power off/on, and performed the final functional test.However, the foot pedal voltage was low of orange pedal, so the fse arranged foot pedal replacement.Root cause - the root cause is confirmed as system error and footswitch failure.Corrective and preventative action (capa) has been raised to investigate "error code displayed on clarity console" and is pending corrective action, if necessary.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY CONSOLE
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20159128
• Report Number: 3006697299-2024-00135
• Device Sequence Number: 12837335
• Product Code: LFL
• UDI-Device Identifier: 10381780126232
• UDI-Public: 10381780126232
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUSA CLARITY FOOTSWITCH (C7002).
• Patient Sex: Unknown