MAUDE Adverse Event Report: ARTHROCARE CORPORATION PROCISE LW COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EICA7070-01
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a bilateral ear tube replacement, microdirect laryngoscopy, bronchoscopy & supraglottoplasty procedure, while the patient had the et tube, scope and a procise coblator ii wand in the airway, the mouth caught into flames.Everything was immediately removed from the patient's mouth/airway and saline was poured onto site.When the patient was stabilized, the area involved was flushed out with saline.It is unknown if the procedure was completed successfully or if there was any delay.Patient outcome is unknown as well.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H2: additional information on: b5, d10 & h6 (impact code).
Event or Problem Description
It was reported that, during a bilateral ear tube replacement, microdirect laryngoscopy, bronchoscopy & supraglottoplasty procedure, while the patient had the et tube, scope and had used a procise coblator ii for 5 minutes in the airway, the mouth caught into flames.A "fire-ball" was noted within the endotracheal tube (positioned in the oropharynx).All tools were immediately removed from the patient's mouth/airway and saline was poured onto site.When the patient was stabilized, the area involved was flushed out with saline.The event terminated the procedure, no further coblation was done.There was no delay since the surgeon was finishing the case when the incident happened.The patient required re-intubation with a new et tube and bronchoscopy was completed for airway assessment.The patient developed significant airway burns and remained intubated for multiple days post-incident.
Additional Manufacturer Narrative
The reported wand and associated controller were returned for evaluation.A visual inspection of the controller 13546-01 serial number (b)(6) found a cracked front bezel, minor scratches and dings, and the bezel dislodged.A visual inspection of the wand eica7070-01 lot number 2128637 found visible tissue build-up and excessive coverage on active electrode, suction port, spacer, and return shaft.Damage to return shaft insulation such as cuts, splitting, as well as thermal degradation and heat exposure were observed at distal end of device.The tip integrity status could not be determined due to significant tissue build-up obstructing view.Significant damage to return shaft insulation was observed at distal end of device.Abrasion marks also observed on proximal bend of shaft insulation near the blue handle.Electrode is present, but unable to determine overall tip and electrode integrity due to excessive tissue build-up and coverage.A functional evaluation of the controller found no problems, and a functional evaluation of the wand found that the wand was unable to test due to significant visual damage and degradation of distal tip/insulation of device.A complaint history review found no similar reported events.A risk management review found that the reported failure and harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of the instructions for use found.¿ do not place instruments near or in contact with flammable materials (such as gauze or surgical drapes).Instruments that are activated or hot from use may cause a fire.¿ do not use flammable anesthetics or oxidizing gases (such as nitrous oxide (n2o) and oxygen) or in close proximity to volatile solvents (such as methanol or alcohol), as fire may result.¿ use care when bending the wand shaft.Aggressive bending could occlude internal suction/saline lines and/or damage the wand shaft insulation.Damaged insulation could lead to unwanted electrical conduction resulting in patient burns.¿ do not allow patient contact with grounded metal objects.¿observe fire precautions at all times.Sparking and heating associated with electrosurgery may be an ignition source.¿ do not use flammable agents for cleaning and disinfection of the controller ¿ do not contact metal objects while activating the wand, as it may damage the tip and/or shaft insulation causing malfunction or injury.¿ avoid contact with metal surgical instruments (such as a mouth guard) as they may pass current to the patient or user and result in burns.A root cause of the reported event could not be determined.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h2: h3, h6: the reported wand and associated controller were returned for evaluation.A visual inspection of the controller 13546-01 serial number (b)(6) found a cracked front bezel, minor scratches and dings, and the bezel dislodged.A visual inspection of the flow control valve 10101 serial number (b)(6) found no issues.A visual inspection of the foot pedal 10863 lot number 345537 found corrosion on the base plate and housing scratches.A visual inspection of the wand eica7070-01 lot number 2128637 found visible tissue build-up and excessive coverage on active electrode, suction port, spacer, and return shaft.Damage to return shaft insulation such as cuts, splitting, as well as thermal degradation and heat exposure were observed at distal end of device.The tip integrity status could not be determined due to significant tissue build-up obstructing view.Significant damage to return shaft insulation was observed at distal end of device.Abrasion marks also observed on proximal bend of shaft insulation near the blue handle.Electrode is present, but unable to determine overall tip and electrode integrity due to excessive tissue build-up and coverage.A functional evaluation of the controller, flow control valve, and foot pedal found no problems, and a functional evaluation of the wand found that the wand was unable to test due to significant visual damage and degradation of distal tip/insulation of device.A complaint history review found no similar reported events.A risk management review found that the reported failure and harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The clinical medical evaluation found contributing factors that cannot be ruled out which are outlined in the instructions for use, such as placing instruments near or in contact with flammable materials (such as gauze or surgical drapes), the use of flammable anesthetics or oxidizing gases (such as nitrous oxide (n2o) and oxygen) or in close proximity to volatile solvents (such as methanol or alcohol), the use of flammable agents for cleaning and disinfection of the controller and other equipment, contact with metal objects while activating the wand, and patient contact with grounded metal objects.It is also noted in the instructions for use that sparking and heating associated with electrosurgery may be an ignition source.It is advised to use care when bending the wand shaft.Aggressive bending could occlude internal suction/saline lines and/or damage the wand shaft insulation.Damaged insulation could lead to unwanted electrical conduction resulting in patient burns, and to avoid contact with metal surgical instruments (such as a mouth guard) as they may pass current to the patient or user and result in burns.A root cause of the reported event could not be determined.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: PROCISE LW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21400312
• Report Number: 3006524618-2025-00064
• Device Sequence Number: 9345295
• Product Code: GEI
• UDI-Device Identifier: 00817470004243
• UDI-Public: 817470004243
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2025

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: 08/08/2026
• Device Catalogue Number: EICA7070-01
• Device Lot Number: 2128637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/24/2025; 03/27/2025; 04/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/28/2025; 03/31/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10101; 10863; 13546-01
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown