MAUDE Adverse Event Report: ARTHROCARE CORP. FLOW CONTROL UNIT; SAW, POWERED, AND ACCESSORIES

Catalog Number 10101

Device Problem No Apparent Adverse Event (3189)

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

Event Type  Injury  

Manufacturer Narrative

Reference: case-(b)(4).

Event Description

It was reported that the flow control unit was not functioning.It would not prime or run fluid at all through the wand, then it started pumping but it was random, like it was out of timing.It was not controlling the flow smoothly.Incident occurred during an adenoidectomy procedure.The circulating nurse had to manually push fluid because a second device was not available.30 minutes of delay were reported.No other complications were reported.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, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection observed that the flow valve piston seems to be pushed into the unit from one side.After opening the unit it was found that a screw that holds the piston to the front of the unit was unscrewed.The unit was returned with a flow cable.The returned cable is ripped exposing internal wire.Functional evaluation revealed the flow valve does function as intended even with its loose piston.The returned flow cable causes the described event to happen.The unit was opened and found a screw loose inside the unit.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.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found smith & nephew reusable flow control valve equipment is subject to various factors that can affect functional life which include frequency of use, method and duration of use, as well as post-operative methods and handling.Proper maintenance of your equipment is essential to achieve optimal performance over time.Symptoms of lifetime failures include but are not limited to the following: connection problems with ancillary equipment.Nicked, cut, or frayed cord.Connected indicator light does not illuminate.Missing/damaged operation controls.Wear smith & nephew recommends returning the device for service if any of the above symptoms cannot be resolved or as needed to maintain optimal performance.The complaint was confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include damage sustained to the device, which could have been caused by running over with another portable object/machine, being stepped on or excessive pulling of the cable or contact to a sharp object.

• Brand Name: FLOW CONTROL UNIT
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11343415
• MDR Text Key: 232377497
• Report Number: 3006524618-2021-00218
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention