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

Catalog Number	EICA8898-01
Medical Device Problem Codes	Overheating of Device (1437); Suction Problem (2170); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Laceration(s) (1946); Partial thickness (Second Degree) Burn (2694)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an oral cavity and oropharyngeal procedure, while using the procise max wand, the irrigation solution seemed to have excessively heated up and seemed to came out fairly quickly, causing a partial thickness with blistering/epidermolysis and blanching on the face and tongue, several centimeters away from the wand's tip.Immediately prior to noticing the burn injury, the operating resident noticed that fingertips (which were holding the tongue >1 cm away from the coblation wand's tip) abruptly became very hot at about the same time as the coblator suction clogged.The settings used were "coblate 7/coag 3".The burn surgery team evaluated the patient intraoperatively and determined that a superficial plasma field injury (chemical burn) had occurred on the left cheek skin and verified that an appropriate approximately neutral ph had been reached after continued irrigation with sterile water, they unroofed a small area with bullous change, they completed the resection and closed.The wound was closed with the use of 4-0 vicryl sutures in combination deep horizontal mattress and simple interrupted fashion superficially, taking care to evert all edges.The tongue stitch was removed.The ventral surface of the tongue was noted to have a small tear from the prior tongue stitch which was also closed with 4-0 vicryl's in a figure-of-eight fashion.This concluded the procedure and the patient was turned over to the anesthesiology team for emergence and extubation.The procedure was completed with a surgical delay greater than 30 minutes.Additionally, the burn was treated with bacitracin ointment, and subsequent dehiscence of the incision bilaterally required surgical revision.The burn is healing well.

• Brand Name: PROCISE MAX 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: 20803583
• Report Number: 3006524618-2024-00510
• Device Sequence Number: 18625661
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: 817470003888
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2024

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 Catalogue Number: EICA8898-01
• Device Lot Number: 2162422
• 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: 11/02/2024
• Initial Report FDA Received Date: 11/28/2024
• Date Device Manufactured: 08/19/2024
• 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: NASOTRACHEALLY INTUBATED WITH THE USE OF VIDEO DIR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown