MAUDE Adverse Event Report: ARTHROCARE CORP. FA COBLATOR II CONTROLLER (120V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-01

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the fa coblator ii controller (120v) did not turn on during set up for a tonsil removal procedure, so a competitor's device was used instead.No delay or 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, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection observed a damaged lid and overlay and the unit is missing two feet.A functional evaluation revealed the fan does not work.The unit was opened and found a cable from the motherboard to the daughterboard disconnected, this cable did not affect the fan spin.Voltages were within their range and everything else worked as intended.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 a repeat issue.Review of the product ifu 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 instructions for use found other than fuse replacement, the controller has no user-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, due to the integrated calibration methods, no annual maintenance check is required.There is no software incorporated in the coblator¿ ii (rf8000e) system controller.If any component malfunctions, call customer service for a return authorization.If a power cord other than the power cord from the manufacturer is used, please ensure the power cord complies with the voltage and current rating listing on the back panel of the controller.Failure to do so may alter the performance of the controller.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.

• Brand Name: FA COBLATOR II CONTROLLER (120V)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11335586
• MDR Text Key: 232148429
• Report Number: 3006524618-2021-00209
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/21/2021

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 Catalogue Number: 13546-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention