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

Catalog Number	C7411S
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Facility reported that during an intracranial tumor (metastatic tumor) removal procedure, a suction malfunction occurred with the cusa clarity 36khz curved extended microtip¿ (c7411s) causing the mist to 'fly away,' resulting in a poor visual field.As a result, the device was replaced with a new one, and the procedure continued without any adverse effects on the patient.However, the surgical time extended by more than 30 minutes.
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
N/a.
Additional Manufacturer Narrative
The cusa clarity 36khz curved extended microtip¿ (c7411s ) was returned for evaluation: failure analysis - a visual evaluation of the returned tip and flue returned did not find any signs of damage, a tip blockage, or anything else that could lead to a suction malfunction.Root cause - the reported issue is not confirmed as no fault was found.The most likely root cause is that the suction tubing had a kink, or that the tubing connection was not adequate; however, the tubing was not returned for evaluation.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• 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: 17923434
• Report Number: 3006697299-2023-00109
• Device Sequence Number: 20526426
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: C7411S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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