MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ CEM NOSECONE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C6623
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cusa excel 23khz cem nosecone (c6623) turned on even though the power button was not pressed.Patient injury and delay in surgery is unknown however, a possibility of burn injury was reported.Another device was used to complete the surgery.
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 excel 23khz cem nosecone (c6623) was not returned for evaluation; 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.Based on the customer reported failure ¿device turned on without pressing power¿ there is insufficient information to provide a possible root cause.Should the product be returned for analysis the complaint will be reopened and evaluation will be completed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
The cusa excel 23khz cem nosecone (c6623) was returned for evaluation: failure analysis - the investigation confirmed that the device failed the closed switch conductivity test, and high dc voltage circuit insulation property test.Destructive testing completed found no evidence of leak path or ingress.As a result, the device will be scrapped.Root cause - the root cause is confirmed as failure of the closed switch conductivity test and high dc voltage circuit insulation property test.The risk remains acceptable per the risk analysis.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 EXCEL 23KHZ CEM NOSECONE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• 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: 20032342
• Report Number: 3006697299-2024-00120
• Device Sequence Number: 3023876
• Product Code: LFL
• UDI-Device Identifier: 10381780026129
• UDI-Public: 10381780026129
• Combination Product (Y/N): N
• PMA/510(K) Number: K141674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: C6623
• Device Lot Number: 7172630
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 01/15/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/06/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sex: Unknown