MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23KHZ SINGLE-SIDED BONE TIP (5-PACK)

Catalog Number	C7421S
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the usa clarity 23khz single sided bone tip (c7421sea) was used for an "intracranial tumor removal surgery¿, and when cutting the internal auditory meatus, damage was observed in the dura mater.The setting of the device when the issue occurred: amplitude 80, tissue select 0, aspiration 90, irrigation 10.The surgeon was not sure if the device touched the dura mater and suspected that the device irradiated ultrasonic waves.However, the surgeon was initially planning to make an incision in the part of dura mater that was damaged; therefore, the event did not interfere with the overall procedure.There was no delay in surgery, and the same device was used to complete the surgery.Additional information received indicating the following: the device did not fall out of the "duty cycle".Its output setting during procedure was as follows; amplitude 80, tissue select 0, aspiration 90, irrigation 10.When the sales rep attended the surgery, it seemed like the surgent did not put too much load on the tip.Other output devices were not used at the same time.
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
The cusa clarity 23khz single-sided bone tip (c7421sea) was not returned for evaluation as the product is not available for return as per customer and lot number information has not been provided; therefore, failure analysis could not be performed, and device history record (dhr) could not be reviewed.A definitive root cause determination is not possible; however, it is most likely that if this damage did occur, the surgeon likely accidentally touched the dura mater with the tip with more load than he intended.This is supported by the report that the part of the dura mater that was allegedly damaged was the intended incision location.Also, as a result, there was reportedly no issue in completing the surgery.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.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY 23KHZ SINGLE-SIDED BONE TIP (5-PACK)
• Common Device Name: CUSA CLARITY
• 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: 20699155
• Report Number: 3006697299-2024-00164
• Device Sequence Number: 6584560
• Product Code: LFL
• UDI-Device Identifier: 10381780536369
• UDI-Public: 10381780536369
• Combination Product (Y/N): N
• PMA/510(K) Number: K221835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: C7421S
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female