MAUDE Adverse Event Report: ARTHROCARE CORP. FLOW CONTROL UNIT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 10101

Device Problem No Flow (2991)

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

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an ent surgery, there was no saline delivered to the wand as the flow control unit was not opening, the light was not turning green when the footswitch was depressed when it was set to the auto mode.They are not able to get the saline to flow when they connect the wand normally.The orange and blue light is still showing when they press the footswitch.The surgery proceeded via an alternative method/ device after the fault was discovered.It is unknown it there was any surgical delay.No injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was no 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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Visual evaluation of the flow valve unit p/n10101, s/n: (b)(6) show no visual damages; the accessory is in its original condition; the manufacturing date is 2020-09-17; during functional evaluation of the flow valve unit p/n10101, s/n: (b)(6) on a lab.Cii cobrator unit p/n13546-02 show a full functional device with no problems; the solenoid and the led performed as intendend also the auto/manual switch is working properly; no manufacturing abnormalities were found during the visual inspection; the complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: FLOW CONTROL UNIT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11731929
• MDR Text Key: 247929284
• Report Number: 3006524618-2021-00518
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1