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

Catalog Number	EIC8898-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/03/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that during an intracapsular tonsillectomy procedure, the specialist used a procise max coblator wand in a 5-year-old patient allegedly without any training or technical knowledge for a tonsil removal and adenoid.A large bleed was reported and had to be contained during surgery.The procedure was completed using the same reported device.There was no surgical delay.The patient was discharged 12 hours after the procedure.It was reported that the patient returned with bleeding, with the patient passing 7 days after the procedure.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H2: additional information: b5, d4 and h4.
Event or Problem Description
It was reported that during an intracapsular tonsillectomy procedure, the specialist used a procise max coblator wand in a 5-year-old patient allegedly without any training or technical knowledge for a tonsil removal and adenoid.A large bleed was reported after the specialist confused the equipment's pedal exchanging cauterization for ablation and had to be contained during surgery after great difficulty.The artery was hit again, opening the bleeding which had to be contained with surgical stitches as it was no longer possible to cauterize it with coblation or bipolar cautery.The procedure was completed using the same reported device.There was no surgical delay.The patient was discharged 12 hours after the procedure.It was reported that the patient returned 2 days later with bleeding; was discharged again, but after 24 hours the patient started coughing with heavy bleeding and was rushed to the nearest hospital, but the patient had already passed away.An autopsy confirmed the rupture of the tonsillar artery, 6 days after the procedure.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified.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 no 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 event was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that based on the information provided the clinical root cause of the reported events were the result of user technique vs procedural variance, which does not represent a device malfunction.The device instructions for use does note that ¿physicians should carefully follow this ifu, particularly the operator training requirements and key steps in system use.¿ the patient impact was determined to be hemorrhaging which resulted in the patient¿s death.Factors that could have contributed to the reported event include lack of user technique and procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Based on this investigation, the need for corrective action is not indicated.

• 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: 19454200
• Report Number: 3006524618-2024-00202
• Device Sequence Number: 17914619
• Product Code: GEI
• UDI-Device Identifier: 00817470007473
• UDI-Public: 00817470007473
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2026
• Device Catalogue Number: EIC8898-01
• Device Lot Number: 2121504
• 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: 05/11/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/10/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Patient Age: 5 YR
• Patient Sex: Female