MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOVIE; REUSABLE CONNECTING CORD

Catalog Number	A1252C
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cord is not being returned by the end customer.Upon evaluation of the information received from the customer, it was confirmed that they were not following the guidelines on our ifu for the a1252c cord.Historical sales prior to the bovie purchase were (b)(4) within since january 2016.Since the bovie purchase, we have sold (b)(4) starting in september 2018.Bovie received 0 complaints of the same issue since january 2016 and this is the first complaint that we have received for the same issue.(b)(4).This can be seen as the final report unless additional information is obtained that alleges the need for additional actions.If so, a follow-up report will be submitted.
Event or Problem Description
The customer alleged that during a procedure, the patient was burned by the cord that attaches to the split pad.

• Brand Name: BOVIE
• Common Device Name: REUSABLE CONNECTING CORD
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8176498
• Report Number: 3007208013-2018-00031
• Device Sequence Number: 16503212
• Product Code: GEI
• UDI-Device Identifier: 10607151001541
• UDI-Public: 10607151001541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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 Catalogue Number: A1252C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1