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

Catalog Number	C7002
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
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
This is 2 of 2 reports linked to mfg report number 3006697299-2024-00135: a facility reported that the cusa clarity footswitch (c7002) voltage was checked prior to surgery and was below the specified value.The device 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
The cusa clarity footswitch (c7002) was not available for return as per the customer.As a result, complaint investigation (failure analysis) and determination of root cause is not possible.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.Based on the customer reported failure ¿voltage was below specified value¿, and with the additional comment that ¿a system error occurred¿, it is possible this complaint was due to an "interface board" issue.However without testing it is not possible to verify.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY FOOTSWITCH
• 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: 20159191
• Report Number: 3006697299-2024-00136
• Device Sequence Number: 8301261
• Product Code: LFL
• UDI-Device Identifier: 10381780126256
• UDI-Public: 10381780126256
• 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,Followup
• Report Date (Section B): 06/30/2026

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: C7002
• Device Lot Number: 7020742-06
• 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: 10/25/2024; 06/09/2026
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/01/2024; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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 CONSOLE (C7000)
• Patient Sex: Unknown