MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ HANDPIECE

Catalog Number	C7036
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during open radical hysterectomy procedure, the connecting part of the tube and the cusa clarity 36khz handpiece (c7036) was broken during surgery.Since the damage of the resin was partial, the physician continued the procedure using the device.No parts were remaining in the patient¿s body; all the broken parts were recovered.There was no surgical delay, and no adverse consequences to the patient were observed.
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 cusa clarity 36khz handpiece (c7036) was not returned; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.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 CLARITY 36KHZ HANDPIECE
• 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: 22180543
• Report Number: 3006697299-2025-00066
• Device Sequence Number: 20932990
• Product Code: LBK
• UDI-Device Identifier: 10381780126263
• UDI-Public: 10381780126263
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: C7036
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2017
• 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