MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C4614S
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 during "left hemi hepatectomy surgery", the cusa excel 36khz curved extended standardtip (c4614s) initially functioned without any issues.However it stopped working, so cem nose cone was removed and reattached, then attempted to use.The amplitude rose only 10%, although the setting was 60 %.Another tip was used, but the amplitude rose only 10%.The procedure was completed by using a crushing clamp.There was no visible misalignment of the handpiece.Malfunction of the tips were suspected.There was surgical delay for more than 30 minutes; however, no adverse consequences to the patient were observed.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The c4614s cusa excel 36khz curved extended standardtip was not returned for evaluation and the lot number is not available; therefore, device history record (dhr) could not be reviewed and failure analysis is not possible.As a result, a definitive root cause determination for this alleged functional issue is not possible, since the product is unavailable for testing.The most probable root cause is generally use error and/or mishandling leading to tip damage.The cusa excel user guide provides guidelines for proper set up, testing and use of cusa tips, and warns against certain conditions, which can lead to partial or full amplitude reduction and/or a tip alarm.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: g3 of initial mdr.This follow-up mdr is being submitted to report the aware date which was erroneously omitted from the initial mdr.The aware date of the initial mdr should read 19may2025.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP
• 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: 22186157
• Report Number: 3006697299-2025-00070
• Device Sequence Number: 18285211
• Product Code: LFL
• UDI-Device Identifier: 10381780026051
• UDI-Public: 10381780026051
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

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: C4614S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/14/2025; 08/19/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/05/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 36KHZ CEM NOSE CONE (C6636).
• Patient Sex: Unknown