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

Catalog Number	C7036
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
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 1 of 3 reports linked to mfg report numbers: 3006697299-2023-00045; 3006697299-2023-00046.A facility reported that cusa clarity 36khz handpiece (c7036) 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the cusa clarity 36khz handpiece (c7036) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) - the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis & root cause - the root cause could not be determined since the device was not returned for evaluation.However, based on the reported complaint "patient received superficial burn", it is possible this complaint is due to the handpiece being connected to a cusa excel/cusa excel+ system that was powered on but not in use, and was unintentionally left beside the patient.The handpiece should have been placed on a sterile, flat, dry, nonconductive, and highly visible surface.Inadvertent contact between handpiece accessories and the patient may result in burns.However, without testing it is not possible to verify.Should the product be returned for analysis the complaint will be reopened and evaluation will be completed.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: 16878797
• Report Number: 3006697299-2023-00044
• Device Sequence Number: 20698224
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Catalogue Number: C7036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 07/28/2023
• Date Device Manufactured: 02/28/2019
• 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 CONSOLE.; (C7411SEA) CUSA CLARITY 36KHZ CRV EXT MICROTIP.
• Patient Sex: Female