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

Model Number	C7036
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a case, the cusa clarity 36khz handpiece (c7036) overheated and got very hot in the surgeon's hand, to the point of almost burning.They were not sure how many times the handpiece was used, but it was in use for about 10 minutes, on and off before the overheating occurred.There was a delay of 15 minutes to get another handpiece, and the surgeon was able to complete the procedure as planned.There was no patient injury.
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
Further investigation was performed, the root cause has been updated to read the following.Root cause - the root cause was confirmed as handpiece "out of specification/overheating." the handpiece was found to be operating out of specification; insufficient irrigation may be the cause for the handpiece to overheat.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.
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 handpiece was overheating as it was out of specification.As a result, this handpiece has been scrapped, the sterile case and torque base have been returned to the customer.Root cause - the root cause was confirmed as "out of specification." 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.
Event or Problem Description
N/a.

• 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: 16916581
• Report Number: 3006697299-2023-00054
• Device Sequence Number: 20513303
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 06/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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