MAUDE Adverse Event Report: SYMMETRY SURGICAL INC RESISTICK II; BLADE ELECTRODE

Catalog Number	ES37T
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information has been provided by the customer.Once we have additional information, a follow-up report will be submitted.
Event or Problem Description
The customer is having a problem with the extended insulation for the electrocautery.The insulation is peeling off and pieces are falling in the patient.
Additional Manufacturer Narrative
The device was not returned for investigation and true root cause.Additionally, the customer never responded with additional information after multiple attempts.There has been a total of (b)(4) sold since 2016 with two similar complaints recorded prior to 2016.((b)(4)).Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional information or corrective actions a follow up report will be submitted.

• Brand Name: RESISTICK II
• Common Device Name: BLADE ELECTRODE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 9491978
• Report Number: 3007208013-2019-00037
• Device Sequence Number: 1810968
• Product Code: GEI
• UDI-Device Identifier: 00607151005757
• UDI-Public: 607151005757
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 09/01/2023
• Device Catalogue Number: ES37T
• Device Lot Number: 0919K
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1