MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA CUSA EXCEL 36KHZ CEM NOSECONE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C6636
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
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
A facility reported that the cusa excel 36khz cem nosecone (c6636) generated power even though the hand switch was not pressed, and it occurred continuously during surgery.Another nosecone was used and it worked properly.No injury was reported, but a possibility of burn injury was reported.There was no delay in surgery.
Additional Manufacturer Narrative
The cusa excel 36khz cem nosecone (c6636) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies were reported that could be related to the reported condition.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.

• Brand Name: CUSA EXCEL 36KHZ CEM NOSECONE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19697434
• Report Number: 3006697299-2024-00091
• Device Sequence Number: 12528272
• Product Code: LFL
• UDI-Device Identifier: 10381780026136
• UDI-Public: 10381780026136
• 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
• 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: 02/28/2026
• Device Catalogue Number: C6636
• Device Lot Number: 7090296
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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