MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C4604ELT
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
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
This is 1 of 2 reports linked to mfg report number 3006697299-2025-00056 for the cusa excel 23khz laparoscopic tip elt (c4604elt): 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa excel 23khz laparoscopic tip elt (c4604elt) incriminated in this complaint was not available for analysis when the integra technician performed the field service.Additionally, lot number information has not been provided; therefore, the device history record (dhr) could not be reviewed.Therefore, this complaint is unable to be confirmed.However, as part of the documentation review, the c4604elt product ifu was reviewed.As per ifu for catalog: c4604elt, it is for use with handpiece c2600 (and not handpiece c2601); this complaint is related to mfg report number: 3006697299-2025-00056 (issue to handpiece c2601).The proper handpiece and tip combination should be used in order to foster proper functionality.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 23KHZ LAPAROSCOPIC TIP ELT
• 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: 22018429
• Report Number: 3006697299-2025-00055
• Device Sequence Number: 18524224
• Product Code: LFL
• UDI-Device Identifier: 10381780025931
• UDI-Public: 10381780025931
• 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): 06/15/2025

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: C4604ELT
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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: CUSA EXCEL HANDPIECE (C2601).; CUSA EXCEL W/ CONSOLE (CUSAEXCEL9).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown