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

Model Number	C7036
Medical Device Problem Codes	Suction Problem (2170); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during an operation while it was working on a patient, the suction on the cusa clarity 6khz handpiece (c7036) stopped and showed on the screen "error: handpiece failure." disconnect and reconnect handpiece.Replace handpiece if error persist.2304 us_invalid_crc_ handpiece." the surgeon who is the main user of cusa in the country was forced to stop the operation and wait until the backup handpiece was sterilized and brought to the hospital.This resulted to the delay of the operation for at least 90 minutes.No patient injury was reported.
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 handpiece (c7036) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis -the investigation of the unit confirmed the complaint: the 36khz handpiece was visually inspected and no visible damage to the handpiece was evident.The handpiece lemo connector was examined further under magnification, and it was observed that the lemo connector pins were corroded.This corrosion seen would possibly inhibit the electrical connection between the handpiece and the console.Repair is not possible; therefore, the handpiece will be scrapped.Root cause - the root cause was confirmed as corrosion to connector pins which caused system error.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 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 ; 6099362319
• MDR Report Key: 16645772
• Report Number: 3006697299-2023-00032
• Device Sequence Number: 20168532
• Product Code: LFL
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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 Model Number: C7036
• Device Catalogue Number: C7036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/30/2023
• 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