MAUDE Adverse Event Report: ARTHROCARE CORP. DYONICS RF-S WHIRLWIND 90 DEG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72202139
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor was using the whirlwind to perform soft tissue ablation during a hip scope case.After 2 hours of intermittent usage, the metal bit on the wand dropped off.He had to use a tissue grasper to pick the bit up, nothing was left in the hip joint.He continued using the wand with no issue for another 15mins and finished the case.No patient injuries were reported.
Additional Manufacturer Narrative
The device, used for treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.Visual evaluation under magnification shows extensive electrode wear; therefore, caused the screen to become detached.There is a significant amount of discoloration on the adhesive around the spacer and on the cap.The black shrink tube near the distal end of the wand shows scratch and scuff marks as well as the cap which is consistent with coming into contact with another metal object and/or prolonged use against a bony surface.There are no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible controller and registered an expected e-5 error.The error was by-passed and activated in saline solution at the default and max settings on the controller and plasma was generated on the remaining electrodes.The suction line was tested and performed as intended.The complaint has been verified and the root cause is consistent with normal wear of the electrodes.Evidence would suggest the electrodes had been virtually disintegrated; therefore, causing the screen to detach.Normal wear of the electrodes is dependent on factors that can accelerate the wear of electrodes such as: extended ablation, use of power level settings above the recommended default levels, and vigorous use against bony surfaces.The instruction for use (¿ifu¿) outlines warnings and precautionary measures to adhere to during activation of the device.There are no indications during manufacturing record review that would suggest the wand did not meet product specifications upon release into distribution.

• Brand Name: DYONICS RF-S WHIRLWIND 90 DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7107971
• Report Number: 3006524618-2017-00412
• Device Sequence Number: 19282404
• Product Code: GEI
• UDI-Device Identifier: 03596010625045
• UDI-Public: (01)03596010625045(17)190831(10)1156895
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K093165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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 Expiration Date: 08/31/2019
• Device Model Number: 72202139
• Device Catalogue Number: 72202139
• Device Lot Number: 1156895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR