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

Model Number EC8000-01

Device Problem Failure to Power Up (1476)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the set up before the surgery when the wand was connected into the flow unit, this one did not switch on.No patient injuries or significant delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.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 evaluation will be reopened for investigation.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.It was determined the device did not contribute to 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed no issues.The flow valve and flow cable functioned with test equipment.When testing this unit with the returned coblator it did not allow the use of auto mode, though the manual function does work no matter which setting it is put into it acts like it is in manual mode.The unit was opened and found no issues.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.No containment or corrective actions are recommended at this time.H11: h2: correction on d1, d4, d8, d9, h6 (health effect - impact code) and h8.

• Brand Name: FLOW CONTROL UNIT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11100541
• MDR Text Key: 224535300
• Report Number: 3006524618-2020-01175
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 00817470001976
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC8000-01
• Device Catalogue Number: 10101
• Device Lot Number: FV15632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1