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

Model Number	C7411SEA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3006697299-2023-00044.3006697299-2023-00046.A facility reported that cusa clarity 36khz curved extended microtip (c7411sea) was used during a "craniotomy occipital right side" for tumor removal, and the patient received a superficial burn on the right scapula and was given first aid treatment with betadine and a duoderm dressing.The handpiece was apparently rested on the scapula on top of the surgical drape.The surgeon's gown had a burn through his surgical gown but had no personal injury.There was no delay in surgery reported.
Additional Manufacturer Narrative
The cusa clarity 36khz curved extended (c7411sea) was not returned for evaluation; therefore, an evaluation of the device could not be performed and the root cause could not be determined.However, based on an evaluation performed by an integra field service technician of the console and handpiece, which found that the aspiration pump had failed, and the information received from the customer stating the following: "the handpiece was apparently rested on the scapula on top of the surgical drape, so the handpiece was intentionally put there, no further details are available on how exactly the burn occurred", it is most likely that the handpiece overheated due to it being inadvisably placed on a drape on the patient's scapula, causing both the actuator pump failure and superficial burn to the patient.Additionally, the cusa clarity 36khz handpiece ifu warns, ¿when the handpiece is connected to a cusa® clarity system that is powered on, but the handpiece is not in use, keep the handpiece away from the patient.Place the handpiece on a sterile, flat, dry, nonconductive, and highly visible surface." if additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (SINGLEPACK)
• 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: 16877461
• Report Number: 3006697299-2023-00045
• Device Sequence Number: 14910338
• Product Code: LFL
• UDI-Device Identifier: 10381780126409
• UDI-Public: 10381780126409
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: C7411SEA
• Device Catalogue Number: C7411SEA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/05/2023
• Date Device Manufactured: 02/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (C7000) CUSA CLARITY 36 KHZ HANDPIECE.; (C7036) CUSA CLARITY 36 KHZ HANDPIECE.
• Patient Sex: Female