MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ CEM NOSECONE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C6636
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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
This report is 1 of 3 and for the cusa excel 36khz cem nosecone (c6636) used which is linked to mfg report numbers: 3006697299-2024-00067 3006697299-2024-00068.A facility reported that their surgical tech put the cusa clarity system together, and when the surgeon went to use it on the liver it malfunctioned.The cusa works by cavitation ultrasonic aspiration and the tip did not move so instead they poked into the liver and caused bleeding.It was quickly fixed using other techniques.A new set of disposables and a new instrument were then assembled and worked appropriately.No additional information has been made available.Customer indicated the following: "reported to fda on 4/16/24.Fda report number: (b)(4).
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: h10.This follow-up report is being sent as a correction for missing information on "related report number" which was not included in the corresponding h10 field of the initial mdr.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cusa excel 36khz cem nosecone (c6636) was returned for evaluation: device history record (dhr) - the dhr of the reported fg lot number was reviewed, and no anomalies were reported during the packaging process.Failure analysis - the investigation showed that the returned device passed all cosmetic and functional testing and meets specification.Based on the reported failure of ¿tip did not move, bleeding¿ it is possible this issue is related to the handpiece.We recommend the removal and servicing of the handpiece.Root cause - the reported failure was not confirmed since the device passed all cosmetic and functional testing and meets specification.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 36KHZ CEM NOSECONE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• 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: 19435425
• Report Number: 3006697299-2024-00066
• Device Sequence Number: 18175123
• Product Code: LFL
• UDI-Device Identifier: 10381780026136
• UDI-Public: 10381780026136
• Combination Product (Y/N): N
• PMA/510(K) Number: K141674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 07/31/2026
• Device Catalogue Number: C6636
• Device Lot Number: 7291716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 11/01/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/10/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: CUSA EXCEL 36KHZ TUBING SET (C3601).; CUSA EXCEL SHEAR TIP 36KHZ (C4617S).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown