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

Model Number	C7023
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Bowel Burn (1756); Blister (4537)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
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
A facility reported that cusa clarity 23khz handpiece (c7023) was not cooling during a hepatectomy procedure.The patient sustained an abdominal burn(not severe, burnt the tissue more than normal) while the assistant had a fingertip burn (not severe, blisters on their finger).No surgical delay has been reported.
Additional Manufacturer Narrative
Additional information received with the following information: product id: c7023p, serial number: (b)(6).
Additional Manufacturer Narrative
The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident were observed.
Additional Manufacturer Narrative
The cusa clarity 23khz handpiece (c7023) was not returned for evaluation (as the facility was unsure on which handpiece they used) therefore, an evaluation of the device could not be performed.Additionally, lot number information has not been provided; therefore, device history record (dhr) could not be reviewed.The root cause of the reported issue could not be determined.Based on the reported failure of "handpiece not cooling, patient and user burned" the complaint may have been a result of cooling system failure.However, without testing device 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.

• 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 ; 6099362319
• MDR Report Key: 15920800
• Report Number: 3006697299-2022-00168
• Device Sequence Number: 11848942
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: C7023
• Device Catalogue Number: C7023P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 02/02/2023; 02/21/2023; 03/14/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/09/2023; 02/23/2023; 03/23/2023
• Date Device Manufactured: 01/11/2019
• 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