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

Catalog Number	C2602
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
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
The cusa excel 36khz straight handpiece (c2602) was tested and emitted an immediate alarm during the surgery when they were ready to set it up.The patient was already under anesthesia; the failure of the kit had influence of increasing the length of the surgery, consequently, the patient stays under anesthesia longer than necessary, and on this occasion, the delay was around 30 minutes as they were under impression of using a new kit and therefore not anticipating any problems.Following the incident, the staff had to locate another device and set it up for the case.The new device was replaced with an existing older device that was in good working condition.However, the device was not used as it would not pass the 10% vibration priming level and was alarming during the test phase.The device was then isolated from the operating field and sent for disinfection.There was no patient injury.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa excel handpiece (c2602) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the failure has been confirmed as transducer delamination which occurs due to degradation of material over time in field.The device will be scrapped.Root cause - the root cause is confirmed as transducer delamination because of transducer braze degrading in the field.Corrective and preventive action (capa) was raised and implemented specific to 36khz handpiece c2602 and transducers involving braze material from supplier which was incorrect and contained zinc.Corrective action implementation date: (b)(6) 2023.The device involved in this complaint was manufactured prior to capa implementation.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT 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 ; 6099362319
• MDR Report Key: 18152899
• Report Number: 3006697299-2023-00121
• Device Sequence Number: 12760369
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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