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

Model Number	EC8001-01
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an ent procedure, when plugged in the coblator ii system did not turn on.A new smith and nephew back-up device was immediately sent which caused a 2 hours delay until the surgeon could finish the procedure, and the patient was under anesthesia all this time.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H2: additional information on a2 and a3.
Event or Problem Description
It was reported that, during an ent procedure, when plugged in the coblator ii system, the pius burned and the device didn´t turn on.A new smith and nephew back-up device was immediately sent which caused a 2 hours delay until the surgeon could finish the procedure.The doctor had to wake the patient up and put him to sleep again two hours later when the replacement device arrived.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on b3 and b5.
Additional Manufacturer Narrative
H10 h3,h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Visual inspection observed the warranty seal is broken, the screws have signs of being removed previously, and the fuse housing is cracked inside from being accessed.The fuses in the fuse housing are installed incorrectly.Functional evaluation revealed the unit has no power when the switch is pressed.Checking the fuses in the fuse housing, they were installed incorrectly by a third party, and one is blown.Replacing and installing the fuses correctly resolved the issue.The complaint was confirmed and the root cause is associated with a component failure.Factors which could have contributed to the identified malfunction, include a blown fuse.No containment or corrective actions are recommended at this time.

• Brand Name: COBLATOR II CONTROLLER (240V)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16000192
• Report Number: 3006524618-2022-00509
• Device Sequence Number: 17544584
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EC8001-01
• Device Catalogue Number: 13546-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 12/28/2022; 07/17/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/28/2022; 12/30/2022; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Male