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

Catalog Number	C4617S
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 2 of 3 and for the cusa excel shear tip 36khz (c4617s) used which is linked to mfg report numbers: 3006697299-2024-00066.3006697299-2024-00068.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 shear tip 36khz (c4617s) was returned for evaluation: there is no reason to test this tip, as it was damaged while being used during surgery, so it will certainly fail the test.Based on that, and based on the fact that the customer did not try replacing just the tip but rather they replaced the tip and handpiece, there is no way to determine if there also could have been an issue with the tip itself.Evaluation of available information and of the returned tip leads to the most likely conclusion being that use error and/or old equipment caused or contributed to the alleged issue during surgery, and to the alleged "bleeding".
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL SHEAR TIP 36KHZ
• 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: 19435401
• Report Number: 3006697299-2024-00067
• Device Sequence Number: 20907697
• Product Code: LFL
• UDI-Device Identifier: 10381780026082
• UDI-Public: 10381780026082
• 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): 06/27/2024

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 Catalogue Number: C4617S
• 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; 06/21/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/10/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 CEM NOSECONE (C6636); CUSA EXCEL 36KHZ TUBING SET (C3601)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown