MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC5872-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tonsillectomy, the evac 70 xtra wand's electrode began to clog.The surgeon tried to clean it with a compress, but it was so hot that it burned the compress.The generator settings were irrigation 3, ablation 7 and hemostasis 3.There was no harm to the patient.It is unknown if there was a back-up device available or if there was a delay.No further complications were reported.Patient's status is good.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively submitting this report in accordance with applicable regulations.If additional 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 a tonsillectomy, the evac 70 xtra wand's electrode began to clog.The surgeon tried to clean it with a compress, but it was so hot that it burned the compress.The generator settings were irrigation 3, ablation 7 and hemostasis 3.There was no harm to the patient.Surgery was completed with the same device.There was no surgical delay, and no further complications were reported.Patient's status is good.
Additional Manufacturer Narrative
H2: additional information in b5 (event).
Additional Manufacturer Narrative
H6: the reported device was received for evaluation.A visual inspection observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is heavily worn from use.The tip has debris trapped in the tip.A functional evaluation of the device found that the wand produced plasma as expected and had no issues activating coag.The tip is partially clogged from the debris trapped in the tip, pressure could not clear it.No overheating of the device was found.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include: 1) using prewarmed saline; 2) insufficient suction pressure in order to ensure adequate flow and circulation of saline solution to prevent unnecessary heating which could have caused the temperature to elevate; 3) the user may not have set the controller temperature threshold to the desired value.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: EVAC 70 XTRA 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: 22491220
• Report Number: 3006524618-2025-00366
• Device Sequence Number: 14502375
• Product Code: GEI
• UDI-Device Identifier: 00817470003185
• UDI-Public: 817470003185
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070374
• 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): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EIC5872-01
• Device Lot Number: 2174540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 08/19/2025
• Initial Report FDA Received Date: 07/13/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2025
• 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
• Patient Sex: Unknown