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

Catalog Number 13546-01

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

It was reported that the foot pedal plug on the generator was loose and not connecting securely.No case involved.Therefore, there was no patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3, h6: 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 that the footpedal port is loose and spins in place, the lid and bezel are damaged, the overlay is dented, and the unit is missing a foot.A functional evaluation revealed no issues.The unit was opened and found no issues.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.

• Brand Name: FA COBLATOR II CONTROLLER (120V)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10254667
• MDR Text Key: 198343361
• Report Number: 3006524618-2020-00458
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 13546-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1