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

Catalog Number	13546-59
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 related failures; this failure mode will be trended to assess for any necessary corrective actions.A visual inspection observed the footpedal port is pushed inside the unit.A functional evaluation revealed the units voltages could not be tested due to the footpedal port damage.The unit was opened and found an inductor coil loose from its saddle inside the unit.The complaint was verified.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include misalignment of the connector when connecting to the unit receptacle in which excessive force or twisting could cause damage.No containment or corrective actions are recommended at this time.There are no indications to suggest that the device/ product did not meet specifications upon release into distribution.
Event or Problem Description
It was reported that the foot pedal insertion was pushed on, the generator was inoperable.It is unknown whether there was a back up available or delay in the case and if the event happened during surgery.No patient injuries were reported.Results of investigation have concluded that this unit had the foot pedal port damaged 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: COBLATOR II CONTROLLER ONLY 120V REFURB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10239823
• Report Number: 3006524618-2020-00443
• Device Sequence Number: 2841741
• Product Code: GEI
• UDI-Device Identifier: 00817470001792
• UDI-Public: 817470001792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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 Catalogue Number: 13546-59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1