MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER (240V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EC8000-01

Device Problem Failure to Power Up (1476)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that the coblator ii generator was switched on and the lights turned on in the morning before the routine check.However, when the case stated and the patient was anaesthetized on the table, the generator could not be turned on.There was no lights nor signs of power.Different power cables were used but again no power came out.The procedure was cancelled in consultation with the patient as they specifically wanted coblation and it was rescheduled for another day.No patient complications were reported.

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.Visual inspection observed the warranty seal is broken.Functional evaluation revealed the unit did not power up or show signs of power.Replacing the fuses resolved the issue.The unit functioned as intended after replacing the fuses.The complaint was confirmed and the root cause is associated with an electrical component failure.Factors which have contributed to the identified malfunction, include a blown fuse.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 found similar reported events.A review of risk management files found that the reported failure was documented appropriately.No containment or corrective actions are recommended at this time.

• Brand Name: COBLATOR II CONTROLLER (240V)
• 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: 13626613
• MDR Text Key: 286362689
• Report Number: 3006524618-2022-00081
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 00817470001976
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC8000-01
• Device Catalogue Number: 13546-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• 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