MAUDE Adverse Event Report: ARTHROCARE CORPORATION REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number EIC4845-01

Device Problem Activation Failure (3270)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that during a septoplasty, the front end of the reflex ultra 45 was not reacting when used.The procedure was completed with a s+n back up device.There was a surgical delay less than 30 minutes and no further complications were reported.Per the preliminary results of the investigation, the functional evaluation revealed intermittent power sparks were observed in the damaged tip assembly above the electrode.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.The electrode has been used and damaged.The tip assembly, that holds the electrode, has been damaged/crushed by another instrument.This finding has been determined to be related to the reported event.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found the wand registered settings (4,2).Plasma was not generated at the electrode but intermittent power sparks were observed in the damaged tip assembly above it.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found 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 the root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include pressing the tip against rough or sharp surfaces or an impact event inconsistent with normal use, thus affecting the wand´s functionality.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H2: additional information in g4 (510k).

• Brand Name: REFLEX ULTRA 45 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: 18640847
• MDR Text Key: 334572233
• Report Number: 3006524618-2024-00050
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EIC4845-01
• Device Lot Number: 2110358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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