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

Model Number	EIC7070-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumonia (2011); Respiratory Arrest (4461); Wheezing (4463); Upper Respiratory Tract Injury (4599)
Date of Event	01/01/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that on literature review the management of infantile tongue base cyst with laryngomalacia, 5 patients had complications after a laryngomalacia procedure using a procise lw coblation wand.1 patient had a disconnection of the tube on the 1st day after the operation, and was not reinserted because of stable breathing and disappearance of stridor at that time, laryngeal stridor appeared again on the 5th day after the operation, it required a revision surgery 1 month after the operation and was intubated for 5 days and recovered well, 3 patients had an intubation time extended to 8 days due to pneumonia, 1 other patient was extubated postoperatively, and on the first postoperative day, laryngeal stridor reappeared, and laryngoscopy revealed epiglottis inversion.The patient was intubated in the icu.The tube was disconnected on the 4th day and the patient died.The reason may be that the tracheal tube was mistakenly inserted into the surgical area of the lingual root cyst during emergency intubation due to the edema and unclear structure of the supraglottic tissue after coblation.This resulted in subcutaneous emphysema in the neck caused by the air flow through the anterior epiglottic space during balloon pressurization for oxygen administration, which aggravated the asphyxia and led to the death of the child.Patients outcome are unknown, except for the one that died.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Paper: the management of infantile tongue base cyst with laryngomalacia 10.13201/j.Issn.2096-7993 2021 06 007.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required, and it cannot be concluded that there was a malperformance of the s&n device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference (b)(4).

• Brand Name: PROCISE LW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14004862
• Report Number: 3006524618-2022-00190
• Device Sequence Number: 4339974
• Product Code: GEI
• UDI-Device Identifier: 00817470000443
• UDI-Public: 00817470000443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: EIC7070-01
• Device Catalogue Number: EIC7070-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown