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

Catalog Number	C2601
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3006697299-2025-00055 for the cusa handpiece ((b)(6)): a facility reported that a patient was burnt during celioscopy procedure due to overheating of the cusa excel handpiece during digestive surgery resulting in a burn to the patient.Additional information has been requested.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 23khz angled handpiece (c2601) was evaluated in the field: device history record (dhr) - the dhr was reviewed, and no anomalies were observed during manufacture or packaging that could be associated with the complaint incident.Failure analysis - through a field evaluation by an integra field service engineer (fse), no problem was found with the handpiece.The handpiece passed all testing and meets specification.Root cause - the complaint is not confirmed.However, a possible root cause for the reported failure is lack of irrigation by the user.If insufficient irrigation fluid is used, this will result in the tip becoming hot during operation, which can then result in burning the patient when it meets human tissue.Additionally, this complaint is related to mfg report number 3006697299-2025-00055 for the tip, and through the investigation for the tip, it has been concluded that "as per ifu for catalogue c4604elt, this tip is for use with handpiece c2600 (and not handpiece c2601).The proper handpiece and tip combination should be used in order to foster proper functionality." moreover, using the incorrect tip can result in putting pressure on the internal parts of the handpiece, i.E.The transducer- which can potentially have an effect on the output of the device.No corrective action 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.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 23KHZ ANGLED HANDPIECE
• 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: 22018659
• Report Number: 3006697299-2025-00056
• Device Sequence Number: 9504818
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C2601
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2020
• 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: CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT; CUSA EXCEL W/ CONSOLE (CUSAEXCEL9)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown