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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3006697299-2025-00095: a facility reported that during an "s6 segmentectomy", an amplitude error occurred when using this loaner cusa excel 36khz curved extended standard tip (c4614s).By using a tip from different lot, it worked properly.There were more than 30 minutes of surgical delay, but no adverse consequences to the patient observed.
Additional Manufacturer Narrative
The c4614s cusa excel 36khz curved extended standardtip was not returned; 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.The alleged amplitude issue could have been caused by a wide variety of possible factors, however without having been present at the time it occurred, and without the return of the product for functional testing, it is not possible to determine the root cause with certainty.The most probable root cause is generally use error and/or mishandling leading to the tip becoming damaged, which could cause an amplitude error, even if it is microscopic damage.The cusa excel user guide provides guidelines for proper set up, testing and use of the cusa tip, and warns against certain conditions, which often lead to partial or full amplitude reduction and/or a tip alarm.No relevant capas were discovered, and no other actions have been identified relating to this issue.No manufacturing, workmanship, or material deficiency was identified for correction because of this complaint investigation.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.
Additional Manufacturer Narrative
Additional information received: the error occurred during surgery.However, there was no surgical delay.Investigation findings: the cusa excel 36khz curved extended standard tip (c4614s) was not returned; therefore, failure analysis is not possible.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The alleged amplitude issue could have been caused by a wide variety of possible factors, however without having been present at the time it occurred, and without the return of the product for functional testing, it is not possible to determine the root cause with certainty.However, the most probable root cause is generally use error and/or mishandling leading to the tip becoming damaged, which could cause an amplitude error, even if it is microscopic damage.The cusa excel user guide provides guidelines for proper set up, testing and use of the cusa tip, and warns against certain conditions, which often 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.

• 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: 22742323
• Report Number: 3006697299-2025-00096
• Device Sequence Number: 7404653
• 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
• Report Date (Section B): 09/15/2025

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
• Device Lot Number: 6984564
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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