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

Model Number	C7023
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the handle on the cusa clarity 23 khz handpiece (c7023) gets hot and is not working properly.No information has been provided on patient involvement, injury, or surgical delay.
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
The cusa clarity 23 khz handpiece (c7023) was returned for evaluation: device history record (dhr) -the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis: evaluation confirmed that the handpiece is overheating when in use.As a result, this handpiece is to be scrapped, and a replacement has been sent to the facility.Root cause: the cause of overheating was not confirmed.Possible causes of overheating per device ifu may be: cusa clarity tips utilize a silicone flue; compressing the flue against the side of the vibrating surface along the length of the tip may cause excessive heating.No further investigation required based on the acceptability of risk and no adverse trends 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 23 KHZ 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 ; 6099362319
• MDR Report Key: 15859178
• Report Number: 3006697299-2022-00161
• Device Sequence Number: 17603764
• 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): 02/09/2023

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 Model Number: C7023
• Device Catalogue Number: C7023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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