MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23KHZ TOUGH TISSUE TIP (5 PACK)

Model Number	C7418S
Medical Device Problem Codes	Crack (1135); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
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
A facility reported that the cusa clarity 23khz tough tissue tip (c7418s) was used for a case as cem nose was needed.The handpiece passed the initial test and the surgeon proceeded with the case.5 minutes later, the amplitude dropped to 20% and the surgeon could not fragment any tumor.Troubleshooting was done by removing the tip, re-torquing, but the 2nd and 3rd tests failed as well.In order to continue the procedure, a decision was made to use 36khz handpiece.After the case, the 23khz tip was inspected and a small crack was noted on the shaft.The event led to increased surgery time of 30 minutes; however, there was no patient injury.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The cusa clarity 23khz was returned for evaluation: failure analysis - evaluation of the returned tip confirmed the reported crack.It is not a full fracture; however, even a small crack has strong potential to cause amplitude issues and errors.Root cause - the root cause is most likely the crack which has the potential to cause amplitude drop during surgery.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.Therefore, no further action is required.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY 23KHZ TOUGH TISSUE TIP (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: 16526476
• Report Number: 3006697299-2023-00028
• Device Sequence Number: 5259086
• Product Code: LFL
• UDI-Device Identifier: 10381780466161
• UDI-Public: 10381780466161
• Combination Product (Y/N): N
• PMA/510(K) Number: K182809
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: C7418S
• Device Catalogue Number: C7418S
• Device Lot Number: 1060404189
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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