MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT 90, ABLATOR, HOOK; ELECTROSURG CUT/COAG DEVICE

Model Number	COOLCUT 90, ABLATOR, HOOK
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a supplier process issue.
Event or Problem Description
It was reported that there is a problem with this item ar-9801 lot 1609050.The expiration date that appears on the label is 31-12-2020 but in the system the expiration date is different 31-12-2022.

• Brand Name: COOLCUT 90, ABLATOR, HOOK
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19370315
• Report Number: 1220246-2024-03642
• Device Sequence Number: 7725113
• Product Code: GEI
• UDI-Device Identifier: 00888867062634
• UDI-Public: 00888867062634
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K023986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: COOLCUT 90, ABLATOR, HOOK
• Device Catalogue Number: AR-9801
• Device Lot Number: 1609050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown