MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA4845-01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a turbinate reduction procedure, four (4) reflex ultra 45 wands were reading 0,2 upon initial plug in.They were tested with three different generators, but the issue persisted.Procedure was canceled after a delay greater than 30 minutes.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(6).
Event or Problem Description
It was reported that during a turbinate reduction procedure, four (4) reflex ultra 45 wands were reading 0,2 upon initial plug in.They were tested with three different generators, but the issue persisted.Procedure was canceled after a delay greater than 2 hours.
Additional Manufacturer Narrative
H10: b4 and h6 updated as per new information received.
Additional Manufacturer Narrative
Correction in h1.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 similar reported events.The instructions for use were 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 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 found that upon wand plug in, the default power level should automatically be set for coblate (4) and coag (2), units that do not default to the correct settings should be rejected.A review of the customer provided image shows the outer box packaging for three wands, and one wand in a tray with no outer box.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 investigation will be reopened for evaluation.Correction in h6 (health effect - clinical & impact codes).

• Brand Name: REFLEX ULTRA 45 COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15440018
• Report Number: 1643264-2022-00340
• Device Sequence Number: 5581750
• Product Code: GEI
• UDI-Device Identifier: 00817470003734
• UDI-Public: 00817470003734
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: EICA4845-01
• Device Catalogue Number: EICA4845-01
• Device Lot Number: 2090410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 12/05/2022; 04/18/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 09/27/2022; 01/09/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown