MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (5 PACK)

Catalog Number	C7411S
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that parts of the flue of the cusa clarity 36khz curved extended microtip¿ (5 pack) (c7411s) were separated.No patient injury has been reported; however, there was surgical delay of more than 30 minutes.No further information was provided by hospital.
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 36khz microtip¿ ((b)(6)) was returned for evaluation: device history record (dhr): the dhr was reviewed and no anomalies were observed that could be related to the reported condition.Failure analysis - one (1) unit was received for evaluation; however, the original product package was not received; therefore, the reported lot number could not be confirmed.The flue component received was visually inspected, and it was observed that it was broken into two pieces: the irrigation tube was separated from the flue body at its base where it connects to the flue body.Therefore, the reported condition is considered confirmed.Root cause - based on the information available, the possible root cause for the reported event is that the flue broke during the setup of the device and not during the packaging process.However, supplier corrective actions were implemented in january 2024 related to broken flues (detached irrigation tubing).

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (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 ; 6099362319
• MDR Report Key: 18461019
• Report Number: 3006697299-2023-00136
• Device Sequence Number: 12549048
• Product Code: LFL
• UDI-Device Identifier: 10381780126355
• UDI-Public: 10381780126355
• 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: User Facility,Company Representative
• 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 Expiration Date: 05/31/2026
• Device Catalogue Number: C7411S
• Device Lot Number: 7041994
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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