MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOVIE; ELECTRODE

Catalog Number	809319
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was sent to teleflex, which is the distributor for the product.Teleflex completed the evaluation of the returned device.The device was purchased from (b)(6) on (b)(6) 2018.Referenced from attached teleflex customer complaint letter: a visual examination was performed and found melted metal on the tips of the returned samples.The area of the melted metal is blackened and mottled which is consistent with electrical arcing, which can only occur when the anode and cathode make direct contact outside of the patient.The complaint is confirmed based on the investigation performed.The root cause for the issue reported could not be determined; however, this does not appear to be a manufacturing related issue.There have been a total of (b)(4) unit sold since 2016 with no additional complaints recorded for similar occurrences.With the information received from the teleflex review and the complaint data, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges a need for any corrective actions are additional patient involvement a follow-up report will be submitted.The delay in the fda receiving this complaint was due to a change in "esignature" certificates.[(b)(4)].
Event or Problem Description
The doctor was using a weck disposable extended blade electrode.Upon inspection by the surgical tech, a portion of the bovie tip was not intact.The bovie tip was replaced and used without further incident.Both the broken bovie and the replacement bovie were retained for inspection.No harm came to the patient.

• Brand Name: BOVIE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8676297
• Report Number: 3007208013-2019-00010
• Device Sequence Number: 19421675
• Product Code: HGI
• UDI-Device Identifier: 10607151009806
• UDI-Public: 10607151009806
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 05/01/2022
• Device Catalogue Number: 809319
• Device Lot Number: 0618E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1