MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC5872-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that t¿s & a¿s surgery was performed on (b)(6) 2020 and an evac 70 xtra wand was used.After procedure, the patient came back with complaints of snoring and struggling to eat.Adhesions formed in nasopharynx and on base of tongue.Apparently taken back to theatre to try and release tension on the palate and tongue.Child stenosed and had to get a tracheostomy.The patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.The responses to clinical information requests were not provided and the s+n device will not be returned to fully evaluate the root cause of the reported events.Per the complaint, after it was reported, the child stenosed a tracheostomy was performed.However, the patient¿s outcome is unknown.Therefore, the patient impact beyond that which has already been reported could not be determined.Should any additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.No further clinical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.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.

• Brand Name: EVAC 70 XTRA COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11859741
• MDR Text Key: 252231544
• Report Number: 3006524618-2021-00647
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003185
• UDI-Public: 00817470003185
• Combination Product (y/n): N
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIC5872-01
• Device Catalogue Number: EIC5872-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention