MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOVIE; BLADE ELECTRODE

Catalog Number	ES37T
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that there is a problem with the resistick coated modified blade electrode.As the surgeon was using it, small pieces of the blade started peeling off.The surgeon attempted with new blades, however, this continued to happen with all the blades.The pieces that fell off were able to be removed from the surgery site with no consequences to the patient.
Additional Manufacturer Narrative
Customer was completing a neuro surgery when the device coating began to peel away.Products were returned through the rma room on date 11/30/2023.All products returned were in new state and had not been taken out of the package.Products returned were taken out of pouch and inspected under magnification for cracks, gaps, or missing coating.No issues with coating or insulator were found.Product is within manufacturing specifications from the visual review.Customer stated during a breast surgery, the physician had the power settings at 40-45watts in coag mode when the coating on the electrode began to fall off.Complaint confirmed from information received from end user.Root cause is determined to be customer misuse in operating the device at too high of a power setting.According to the attached mc-18963 rev 12 - " use of electrode with modified insulation in contact with tissue or fluid may cause splitting or peeling back of the modified insulation on the electrode.Always use the lowest power setting that achieves the desired surgical effect.Use the active electrode for the minimum time necessary in order to reduce the possibility of unintended burn injury.Using the coated electrode at a high power setting may cause damage to the coating." this is the second complaint of its kind in the last 2.8 years of complaint reviews.In the same time period, we have sold 17316 number of eaches.0.0115% = low based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: BLADE ELECTRODE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18282837
• Report Number: 3007208013-2023-00059
• Device Sequence Number: 20507379
• Product Code: GEI
• UDI-Device Identifier: 10607151005754
• UDI-Public: 10607151005754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: 05/01/2026
• Device Catalogue Number: ES37T
• Device Lot Number: 0522Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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