MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE

Catalog Number C7000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Inflammation/ Irritation (4545); Easy Bruising (4558)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports linked to mfg report number 3006697299-2023-00077, as the facility is unable to determine which cusa device was involved: a facility reported that cusa clarity console (c7000) was used and undistinguishable marks were observed on a patient post liver surgery.The marks/injury did not show until the patient arrived on the nursing floor.Therefore, the exact machine, handpiece and disposables were not sequestered, and as a result, the facility is unable to identify which of their 2 cusa consoles was involved.The devices that were used during surgery were retractors, aquamantyss and one (1) cusa along with the traditional cautery devices.Additional information has been requested.

Manufacturer Narrative

Additional information received on 7/20/2023: 1.Was there any medical/surgical intervention after marks were observed on the patient? no.1.If yes, please provide details (treatment and/or medication administered).1.What is the health history of the patient? history of hepatoblastina s/p chemo.2.In relation to the injury sustained, please advise of patient outcome or the status of the patient.Healing.3.Were two consoles used during surgery? no.4.If an issue was detected with one console what alarms, error codes, defect etc was noted? n/a.5.What are the serial numbers for the footswitches used with each console? no idea.6.What are the serial numbers for the handpieces that were used with each console? no idea.Summary of phone call with facility's surgeon on (b)(6) 2023: surgeon explained surgery on an infant 6-9 months old to remove liver tumor.When surgery was completed burn marks along skin or what looked like scalding noticed on patient.The family was advised, and the family has filed a grievance against (b)(6) hospital and is seeking compensation.Surgeon stated he used the monopolar cautery device, cusa and aquamantys during the surgeon and he had never experienced anything like this before.As a result, he spoke with the transplant surgeon to see what settings were used with the aquamantys device and was told it was a 6-temperature variable.He spoke with the neurosurgeon to see if he had ever experienced anything like this and was told no.He wanted to know what settings we recommend for the cusa handpiece and if there were any process improvements, he could learn from this.Integra representative (ir) explained that the handpiece only provides power at the tip; nothing to the cable or flue.It was explained that the handpiece provides amplitude 60-100%, aspiration is typically the same as amplitude 60%, irrigation is 3ml per minute using saline to emulsify.He explained that the water is at room temperature 22c and the body temperature is at 37c, and surgeon concluded it could never get hot enough since body temperature could not cause such a burn.Surgeon asked how do you know the correct tissue selection to choose which is 0 to 4, how do you gauge? ir explained it would depend on the type of surgery, if bloodless liver surgery was done for example.The higher the number selection, the better preservation of tissue.Ir asked surgeon how the handpiece was stored when not using.Surgeon responded, ¿handpiece is put into the holster.¿ ir explained unless you step on pedal no energy comes out of the tip.Ir asked if the patient was draped and surgeon stated ¿no¿, there were no drapes on the patient.He also asked if other metal instruments were touching the area.Ir suggested we could obtain the logs from the units which would answer such questions as settings used and how long the foot pedal was activated.Product return evaluation findings: the cusa clarity console (c7000) was returned for evaluation.Device history record (dhr) - the dhr documentation was reviewed and the following anomalies that could be associated with the complaint incident was observed.Failure analysis: model cusa clarity console serial#: (b)(6) serviced on 15-jun-2023.Incoming inspection showed system worked okay with no fault found.However, the software was upgraded to the latest, and the battery and ground finger were replaced.Subsequently, the system was tested, calibrated to specifications and is ready for use.Next preventative maintenance (pm) due date: jun-2024.Root cause: the device passed all cosmetic and functional testing and meets specification.No issue was determined.A medical assessment was performed to determine causality which concluded that due to the loss of the product, insufficient evidence exists to confirm or suggest a causal relationship to the device.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 any similar issues.

Event Description

N/a.

Manufacturer Narrative

Updated fields: g3, g6, h2, h10 (investigation findings only) investigation findings: the cusa clarity console (c7000) was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and the following anomalies that could be associated with the complaint incident were observed.Failure analysis - model cusa clarity console serial# (b)(6) serviced on (b)(6) 2023.Incoming inspection showed the system worked okay with no fault found.However, the software was upgraded to the latest, and the battery and ground finger were replaced.Subsequently, the system was tested, calibrated to specifications and is ready for use.Next preventative maintenance (pm) due date: jun-2024.Review of log files was completed, and said review certainly supports the conclusion that the cusa clarity with 36 khz handpiece could not contribute to the marks on the patient abdomen as shown in this complaint.The log files show normal levels which indicated reasonable frequency and expected performance.Total vibration was 7 minutes 35 seconds.Most ultrasonic activation time on events were less than 30 seconds, and there was only 1 event at more than a minute at 65 seconds.There was periodic usage consistent with normal surgeon actions.We believe this is a very short usage time for a surgery in the liver and the pedal was certainly not depressed for any long period accidentally.The default amplitude, aspiration, and irrigation were maintained.The surgeon had indicated that the handpiece was placed in a plastic holster when not in use with the patient.These are very reasonable settings and with the duty cycle and on time, no significant heating would be expected.Root cause - the device passed all cosmetic and functional testing and meets specifications.No issue was determined.A medical assessment was performed to determine causality which concluded insufficient evidence exists to confirm or suggest a causal relationship of burn marks on skin to the cusa device.Trends will be monitored for this and any similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: CUSA CLARITY CONSOLE
• Type of Device: 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: 17364770
• MDR Text Key: 319448698
• Report Number: 3006697299-2023-00078
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780126232
• UDI-Public: 10381780126232
• Combination Product (y/n): N
• PMA/PMN Number: K161882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1