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

Catalog Number	C4601S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the cusa excel 23khz standardtip (c4601s) broke off during an unspecified surgery without any excessive force used.The broken part fell into the surgical site and was retracted by forceps.There was no significant surgical delay and no patient injury occurred.
Additional Manufacturer Narrative
Cusa excel 23khz standardtip (c4601s) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies wee observed that could be related to the reported condition.Failure analysis - evaluation of the returned tip confirmed that it is fractured off at the distal end.The cusa excel ifu lists the warnings and cautions that could be related to the reported condition: when the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece and require replacement before use.Avoid excessive lateral loading of cusa excel tips.This may result in injury to the patient and/or user, or equipment damage.Avoid contacting bone with the cusa excel tips.When testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation.Contact may result in injury to the patient and/or user, or handpiece tip damage.Turning the torque wrench further clockwise will damage the handpiece.Root cause - the root cause is most likely that one or more of the above warnings was not avoided.The damage is indicative of contact with a hard object during tip activation, or possibly prior to testing, causing a crack which ultimately fractured off when tested.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 23KHZ STANDARDTIP
• 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: 20158062
• Report Number: 3006697299-2024-00137
• Device Sequence Number: 19886085
• Product Code: LFL
• UDI-Device Identifier: 10381780025900
• UDI-Public: 10381780025900
• 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
• Report Date (Section B): 09/06/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: C4601S
• Device Lot Number: 7092645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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