MAUDE Adverse Event Report: ARTHROCARE CORPORATION REFLEX ULTRA PTR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number EICA4835-01

Device Problems Failure to Conduct (1114); Premature End-of-Life Indicator (1480)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that during an ent procedure, when two (2) reflex ultra were plugged in, they displayed "expired handpiece".The procedure was completed with a competitor device and with a surgical delay greater than 30 minutes.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.Visual inspection observed the two returned instruments show no manufacturing abnormalities.The electrodes have not been used.Both devices were out of the original packaging.No packaging returned.A functional evaluation showed both the opened devices were plugged into the controller and registered settings (0,2).When used with a bypass box, both the wands were able to generate plasma and coagulation as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the activity test workmanship found that the operator must verify the default setting and should reject units that do not default to the correct settings.The root cause can be attributed to the user.Factors that could have contributed to the reported event include previous use and connecting and disconnecting the wand.No containment or corrective actions are recommended at this time.

• Brand Name: REFLEX ULTRA PTR COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18236644
• MDR Text Key: 329356705
• Report Number: 3006524618-2023-00483
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003871
• UDI-Public: 00817470003871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EICA4835-01
• Device Lot Number: 2114123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1