MAUDE Adverse Event Report: ARTHROCARE CORPORATION COBLATOR II (120V) SRVC CONTROLLER PACK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-59F

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Electric Shock (2554)

Event Date 02/20/2017

Event Type  Injury  

Event Description

It was reported that during a turbinate ablation, the doctor felt as if the patient might have had some electric shock while using this product.The surgeon monitored patient for an hour to ensure no issues.The patient complained of a bad headache after the procedure but no other complications have been reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection revealed a few minor scratches on the exterior of the returned device.Functional evaluation revealed the subject controller performed as intended and exhibited no functionality issues during the testing process.At no time during testing did the subject controller show any kind of error message or fail to activate a known good wand several times without incident.All of the ablation and coag voltage output readings were within specified ranges when the subject controller was tested.The complaint could not be verified and a root cause could not be determined in association with the subject controller due to the subject unit functioning as intended when tested.Precautionary statements in the user's manual include: a thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device and other medical instruments.Ensure that insulation or controller grounding is not compromised.Do not wrap patient cable around metal objects.Wrapping cords around metal objects may induce currents that could lead to shocks, fires, or injury to the patient or surgical personnel.Do not allow patient contact with grounded conductive objects, such as a surgical table frame or an instrument table, to avoid risk of shock.Grounding pads should not be used.Do not contact metal objects with an activated wand.As with other electrosurgical units, electrodes and cables can provide paths for high frequency current.Position the cables to avoid contact with the patient or other electrical leads.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: COBLATOR II (120V) SRVC CONTROLLER PACK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6381111
• MDR Text Key: 69171336
• Report Number: 3006524618-2017-00054
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 13546-59F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other