MAUDE Adverse Event Report: ARTHROCARE CORPORATION 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	05/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error e5 appears on the screen indicating that the probe is reused but it is new.Problem resulted in an extended surgical time.No patient injuries were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.Factors that could have led to an e-5 error includes: the rf controller may have been turned off following connection of the wand or source power may have been interrupted.The dyonics rf-s whirlwind 90 deg wand incorporates a single-use feature which is designed to prevent reuse of the wand.There are other factors that could contribute to an e-5 error such as disconnecting the wand from the controller after power has been turned on, previous use or incorrect power cycling of the controller.Also, a reprocessed wand used by the customer will exhibit an e-5 error.

• Brand Name: DYONICS RF-S WHIRLWIND 90 DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7679273
• Report Number: 3006524618-2018-00370
• Device Sequence Number: 16493313
• Product Code: GEI
• UDI-Device Identifier: 03596010625045
• UDI-Public: (01)03596010625045(17)190531(10)1151224
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K093165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: 05/31/2019
• Device Model Number: 72202139
• Device Catalogue Number: 72202139
• Device Lot Number: 1151224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1