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

Catalog Number	C7000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during an unspecified surgery the cusa clarity console would not turn on.It is probable there was increased surgical time of 30 minutes or more.Additional information received on 12 oct 2024: could you please clarify the duration of the intervention time: less than 30min or equal to/greater than 30min? indeed, was greater than 30 min.Date of the event? 20 sept 2024.How could the intervention have been finalized? change of method ¿ dissection in the plane of the tumor cleavage (chance for the patient to have a tumor capsule and metastasis).
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa clarity console (c7000) was returned for evaluation: 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 that the interface board failed, possibly due to the power on/off circuit located on the interface board failing to work.The interface board was replaced and the old one scrapped after replacement in the field.Preventive maintenance was also performed and the console passed the test per manufacturer specifications.Root cause - as the interface board was scrapped after field service was completed, testing is not possible to verify and determine the root cause.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY CONSOLE
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20451970
• Report Number: 3006697299-2024-00156
• Device Sequence Number: 18273775
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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
• Patient Sex: Unknown