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

Model Number EICA8872-01

Device Problems Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that there was a little lip burn when using the procise coblator ii.It is unknown if there was a back-up device available or if there was a delay.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.Product was out of the original packaging.No packaging returned.The device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation as intended.Saline and suction both performed as intended.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 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 this case reports the patient experienced ¿a little lip burn¿ when the procise coblator wand was used.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Additionally, no information regarding whether a back-up device was used, or a procedural delay occurred.The patient impact beyond the reported cannot be determined.The root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: PROCISE XP 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: 15698461
• MDR Text Key: 302687137
• Report Number: 3006524618-2022-00467
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003727
• UDI-Public: 00817470003727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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
• Device Model Number: EICA8872-01
• Device Catalogue Number: EICA8872-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other