MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT 90,ASP ABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number COOLCUT 90,ASP ABLATOR

Device Problems Smoking (1585); Sparking (2595)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that the head of the device sparked and smoked and charred.There was no harm for patient, operator or third party reported.This was noticed before the surgery.No further information received.Update (b)(6) 2023.It was confirmed that the device was used with a generator from another manufacturer.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

One unpackaged ar-9803a-90 arthrex coolcut®, aspirating ablator, 3 mm, 90 serial/batch number: (b)(6) was received for investigation.Functional testing was not performed because the device connector switch is incompatible with the testing equipment.Visual inspection did not identify issues with the device.However, by the complaint event description, the equipment was used: "with a generator from another manufacturer (erbe)" according to dfu-0088-2, rev.0 monopolar ablation probe.

• Brand Name: COOLCUT 90,ASP ABLATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16120590
• MDR Text Key: 308712511
• Report Number: 1220246-2023-06058
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867062726
• UDI-Public: 00888867062726
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K203986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COOLCUT 90,ASP ABLATOR
• Device Catalogue Number: AR-9803A-90
• Device Lot Number: 2106216
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1