MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23KHZ CEM NOSECONE (5 PACK); CUSA CLARITY NOSECONE

Catalog Number	C7523
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/16/2024
Type of Reportable Event	Serious 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.
Event or Problem Description
A facility reported that the the cusa clarity 23khz cem nosecone (c7523 was used in a laparoscopic hepatectomy procedure, and 30 minutes after liver section started, the device turned on even though the button on the cem nosecone was not pressed.The patient¿s skin got burned approximately 1cm in diameter, since the device was placed right under a port.The surgeon stopped using the device and the procedure was completed using a standard nosecone.According to further investigation, one of the connector pins was missing and the missing pin was not returned.According to the sales rep, the pin was removed at the hospital.The generator that was used with the product was zeruk / mera.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa clarity 23khz cem nosecone (c7523) was returned for evaluation: device history record (dhr) review- 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 device failed the open and closed switch conductivity test.Destructive testing was completed and found no evidence of leak path or ingress found.Root cause - the root cause is confirmed as a failed closed switch.As a result, the device has been scrapped.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.

• Brand Name: CUSA CLARITY 23KHZ CEM NOSECONE (5 PACK)
• Common Device Name: CUSA CLARITY NOSECONE
• 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 08540 ; 6099362319
• MDR Report Key: 19282657
• Report Number: 3006697299-2024-00058
• Device Sequence Number: 12608479
• Product Code: LFL
• UDI-Device Identifier: 10381780466215
• UDI-Public: 10381780466215
• Combination Product (Y/N): N
• PMA/510(K) Number: K190180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: C7523
• Device Lot Number: 7068230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: ZERUK/MERA GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown