MAUDE Adverse Event Report: ARTHROCARE CORP. RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 28168-59S

Device Problems Failure to Power Up (1476); Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, functional testing could not be performed. visual inspection observed the lid and bezel are damaged and the unit is missing a foot. functional evaluation revealed the unit presents f4 fault on power up.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.The complaint was confirmed and the root cause is associated with a component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.A corrective action has been initiated to mitigate future recurrence of similar events.

Event Description

It was reported that the controller had different failures.No case involved.Results of investigation have concluded that this unit presents f4 fault on power up which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11323178
• MDR Text Key: 231659743
• Report Number: 3006524618-2021-00191
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28168-59S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• 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: Unknown
• Patient Sequence Number: 1