MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) POOL CUSA CLARITY 23KHZ HANDPIECE

Catalog Number	C7023P
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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 3006697299-2024-00080: a facility reported that when they opened the rental cusa clarity 23khz handpieces (c7023p) upon arrival, there was a significant amount of dried blood in the irrigation canal which was most likely left over from the previous rental/loaner use.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The pool cusa clarity 23khz handpiece (c7023p) was not returned; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Due to lack of information, it is not possible to give a possible root cause.The device was decontaminated before being dispatched to the customer.Images of the material were requested, but none were made available.As the handpiece was not returned for investigation and was cleaned at the customer site, it is not possible to identify the material found inside the handpiece.If images or other information are made available, the complaint will be reopened, and the respective evaluation will be completed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: POOL CUSA CLARITY 23KHZ HANDPIECE
• 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: 19489569
• Report Number: 3006697299-2024-00081
• Device Sequence Number: 8538173
• Product Code: LFL
• UDI-Device Identifier: 10381780466314
• UDI-Public: 10381780466314
• Combination Product (Y/N): N
• PMA/510(K) Number: K182809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: C7023P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2020
• 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