MAUDE Adverse Event Report: ARTHROCARE CORPORATION REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA4845-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Coma (2417)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, an 11-year-old patient underwent a routine tonsillectomy in which a coblation halo wand device was used.Three days after the surgery, the patient began vomiting blood and experienced bleeding from the carotid artery, requiring emergency surgery.During the procedure, the patient went into cardiac arrest for nearly 10 minutes.The patient was resuscitated and placed in a medically induced coma for 10 days.At present, the patient is relearning how to eat, talk, and walk.Although recovery is expected, additional surgeries are planned due to a blood clot in the artery.The cause and further details of the event are unknown at this time.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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.
Additional Manufacturer Narrative
H11: corrected information in b1.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that in (b)(6) 2025, an 11-year-old patient underwent a routine tonsillectomy in which a reflex ultra 45 coblator ii wand was involved.Following the procedure, the patient experienced post-tonsillectomy hemorrhaging, which required interventional radiology (ir) coil embolization.Three days after the surgery the patient began vomiting blood and bleeding from the carotid artery, resulting in surgery, in which, the patient went into cardiac arrest for nearly 10 minutes.The doctors were able to save him, but they had to be placed in medical induce coma on (b)(6) 2025, for 10 days.Currently, the patient is relearning how to eat, talk, and walk.The doctors are expecting to recovery; however, the patient has upcoming surgeries due to a blood clot in his artery.The cause and further details are unknown at this time.

• Brand Name: REFLEX ULTRA 45 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21932543
• Report Number: 3006524618-2025-00202
• Device Sequence Number: 9021925
• Product Code: GEI
• UDI-Device Identifier: 00817470003734
• UDI-Public: 817470003734
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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 Expiration Date: 07/21/2026
• Device Model Number: EICA4845-01
• Device Catalogue Number: 72290134
• Device Lot Number: 2124652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/06/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 40 KG