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

Model Number	ES58T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was returned, additional information was not provided by the end customer.Our distributor would not provide any of the user facility's information and stated that the customer was not responding to their requests for additional information.The lot number was not provided.Upon receiving the returned device, it appeared to have sever damage with the sterile wrapper melted onto the product.The product was missing the bio-coating on the tip which could be come damaged due to using a scratch pad or abrasive material when cleaning the tip.A true root cause could not be determined without additional information from the customer.There has been a total of (b)(4) sold since 2016 with no additional complaints recorded for this occurrence and is therefore an isolated event.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any other patient involvement or a need for any corrective actions a follow-up report will be submitted.
Event or Problem Description
The blue coating is chipping off into the patient.The was no harm to the patient as a result.

• Brand Name: RESISTICK
• Common Device Name: BLADE ELECTRODE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8838759
• Report Number: 3007208013-2019-00027
• Device Sequence Number: 16520010
• Product Code: GEI
• UDI-Device Identifier: 00607151005634
• UDI-Public: 607151005634
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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 Model Number: ES58T
• Device Catalogue Number: 83615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1