MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF ENT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 72290144

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Information (3190)

Event Date 09/15/2020

Event Type  Injury  

Event Description

It was reported that during a surgery the werewolf had no energy coming trough.The procedure was completed without delay.A competitor device was used.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the operations service manual found the following warnings and precautions the controller has no operator-serviceable parts.It is designed to provide consistent output levels and is calibrated by clock crystals, voltage references, and fixed resistors.There are no internal adjustments in the instrument and no annual maintenance check is required.If a component malfunctions, call customer service for a return authorization.For flow¿ wands and werewolf¿ ent wands, the output voltage and power are automatically set for each mode and each level within a mode; they are specifically tuned for each wand.For flow wands, the outflow through the wand is continuously adjusted by the system as a function of many parameters including the wand type, the mode selected, and the properties of the plasma formed at the tip of the wand.Once a wand has been properly connected, the modes and levels can be selected by touching the display on the screen.An ablation mode can also be selected by pressing the mode button on the foot control or the mode finger switch on the handle of the wand, if available.For black connector quantum¿ compatible wands, the voltage output is independent of the wand and only controlled by the setpoint.Electric shock hazard: do not connect wet connector to the controller.Ensure that all accessories are securely and properly connected.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Visual inspection observed no issues.Functional evaluation revealed no issues.The unit was opened and found no issues.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: WEREWOLF ENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10635485
• MDR Text Key: 210005898
• Report Number: 3006524618-2020-00856
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556739624
• UDI-Public: 00885556739624
• Combination Product (y/n): N
• PMA/PMN Number: K192027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 72290144
• Device Catalogue Number: 72290144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2021
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/03/2020; 10/14/2021
• Supplement Dates FDA Received: 11/04/2020; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention