MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. EXCEL 23KHZ ANGLED HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2601
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 prior to an unspecified surgery, the cusa excel 23khz angled handpiece (c2601) was defective.The exact device malfunction is not known, but the patient was prepared/under anesthesia at the time, there was increased surgical time as a result.The handpiece was used with an old console cusa excel8, which is not repairable.Additional information received from the customer: "the surgeon does not want to answer the questions "your sales rep informs me that no repair is possible on our device because you have declared it obsolete.Your questions are therefore irrelevant." the surgeon does not want to answer the questions.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 23khz angled handpiece (c2601) 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.Due to lack of information, it is not possible to give a possible root cause.Should the handpiece 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.

• Brand Name: EXCEL 23KHZ ANGLED HANDPIECE EACH1
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21708694
• Report Number: 3006697299-2025-00036
• Device Sequence Number: 10010676
• Product Code: LFL
• UDI-Device Identifier: 10381780039426
• UDI-Public: 10381780039426
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: C2601
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2005
• 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: CUSAEXCEL8 CONSOLE
• Patient Sex: Unknown