MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2602
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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
An authorized distributor reported that the cusa excel 36khz straight handpiece (c2602) was heating during a liver surgery and had low amplitude output.There was no patient injury and no delay in surgery.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr) review - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint as valid: the handpiece has no amplitude - 10%, the stroke is unstable and the transducer is faulty.As a result, the transducer the housing and o-rings are to be replaced during repair.Root cause - the root cause is confirmed as transducer failure.Based on the reported failure of ¿low amplitude output and heating with c4614s tip¿, and after a discussion with the site manufacturing engineer, the heating may have been caused by misuse.If the handpiece tip is pressed into tissue and stalls, this can result in the handpiece still trying to deliver power to the tip which can result in heating.This may have resulted in the transducer failure.If there is no amplitude and low stroke in the handpiece, this will result in low to no power being delivered to the tip.Therefore, the tip would not heat up.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• 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: 21283178
• Report Number: 3006697299-2025-00007
• Device Sequence Number: 20778910
• Product Code: LFL
• UDI-Device Identifier: 10381780039433
• UDI-Public: 10381780039433
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: C4614S CUSA TIP.
• Patient Sex: Unknown