MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FLOW 50 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290037
Medical Device Problem Codes	Material Separation (1562); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a surgery, one (1) werewolf flow 50 coblation wand displayed the error message "wand short circuit".Also, when the wand was removed from the joint, it was noticed that a tip electrode fell off inside the patient¿s body.The tip electrode was removed from the body.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The electrode and spacer at the tip of the wand have fully fallen off.The spacer and electrode were returned with the device.The saline line as been cut from the device.A functional evaluation was performed on the returned device and found a wand end of life error.The wand was not tested for activation due to the damaged tip.However, wand data shows the wand experienced a wand shorted notification error.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.A definitive root cause for the failures could not be determined.Factors that could have contributed to the short error include moisture in the connection causing a wand short, incomplete connection, or the wand´s connector or cable got damaged.Factors that could have contributed to the failure include 1) hitting the device tip against a hard surface.2) using the device as a lever to enlarge surgical site.3) mechanical displacement of tissue through applied force.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: WEREWOLF FLOW 50 COBLATION WAND
• 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: 24912109
• Report Number: 3006524618-2026-00190
• Device Sequence Number: 9828173
• Product Code: GEI
• UDI-Device Identifier: 00885556617472
• UDI-Public: 885556617472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 72290037
• Device Lot Number: 2202994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2025
• 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