MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EFLEX ABLATOR PROBE INTEGRATED CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72200683
Medical Device Problem Codes	Failure to Deliver Energy (1211); Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a hip arthroscopy surgery, the e flex ablator was not as aggressive as it once was.Additionally, the flex ablator left behind a black residue on the tissue/labrum after use.It was described as a black "grease" type residue.The device did not flake into any debris.The procedure was successfully completed with a delay of 1 minute using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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 clinical review states that while using the e flex ablator a black residue was left behind.It was communicated via e-mail that there were multiple problems with the same wand.It was also noted that, ¿no flakes from the device itself were left in the patient¿ and ¿the product was thrown out in the hustle of turnover.It will not be returning.¿ based on the limited information provided, the definitive clinical root cause of the reported adverse event cannot be determined.According to case details, the procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.According to case details, the procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: EFLEX ABLATOR PROBE INTEGRATED CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18455531
• Report Number: 3003604053-2024-00002
• Device Sequence Number: 16919265
• Product Code: GEI
• UDI-Device Identifier: 03596010601421
• UDI-Public: 03596010601421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 72200683
• Device Lot Number: 7928507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/16/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown