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

Catalog Number	C2602
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during surgery, the ultrasound from the cusa excel 36khz straight handpiece (c2602) was too low.There was increased surgical time of 30 minutes; however, there was no patient 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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: the transducer has very low power and is out of specifications.The top layer of the connector plug is damaged (the device was improperly decontaminated) and the plug has to be replaced, and the wire at the plug side is broken and needs to be re-soldered.To resolve the issues, the green wire on the plug side has been re-soldered, and the plug, housing and all o-rings have been replaced.Additionally, a full function test including calibration and safety test according to the manufacturer's guidelines has been performed.Root cause - the root causes for the reported complaint are confirmed as follows: ¿ a defective transducer; ¿ a damaged connector plug- (the device was improperly decontaminated); and ¿ the wire at the plug side is broken and needs to be re-soldered due to wear and tear.No further investigation is required based on the acceptability of risk and no adverse trends 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 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: 21282912
• Report Number: 3006697299-2025-00010
• Device Sequence Number: 7782177
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 03/19/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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