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

Model Number EIC7071-01

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

Patient Problem Swelling/ Edema (4577)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, after a cordectomy procedure was performed with the procise mini laryngeal wand, the patient required late hospitalization due to severe edema of the larynx.Intraoperatively, ablation and coagulation worked correctly.Patient outcome is unknown.

Event Description

It was reported that, after a cordectomy procedure was performed with the procise mini laryngeal wand, the patient required late hospitalization due to severe edema of the larynx.Intraoperatively, ablation and coagulation worked correctly.Patient outcome was good.Patient recovered satisfactorily.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 complaint history review found similar reported events.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 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 no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition was reported as ¿good¿ and it was also noted that the ¿patient recovered satisfactorily.¿ should any additional clinical information be provided this complaint will be re-evaluated.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant 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.

• Brand Name: PROCISE MINI LARYNGEAL COBLATOR II
• Type of Device: 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: 12483868
• MDR Text Key: 271794353
• Report Number: 3006524618-2021-00915
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000597
• UDI-Public: 00817470000597
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: EIC7071-01
• Device Catalogue Number: EIC7071-01
• Device Lot Number: 2051355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 12/06/2022
• Supplement Dates FDA Received: 10/04/2021; 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female