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

Model Number	EC8001-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that when the coblator ii system (240 v) was ready to be connected, smoke occurs, after smoke, the product cannot be turned on.The procedure was finished with a smith and nephew backup device.It is unknown when the incident occurred and if occurred a surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.Visual inspection of the customer provided picture identifies the unit but does not provide complaint related information.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.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: COBLATOR II SYSTEM (240 V)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11995917
• Report Number: 3006524618-2021-00710
• Device Sequence Number: 3202349
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: EC8001-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1