MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SCISSOR

Model Number	57-2610
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Scissor tip broke during surgical procedure.

• Brand Name: SYMMETRY SCISSOR
• Common Device Name: SCISSOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7844547
• Report Number: 3007208013-2018-00020
• Device Sequence Number: 19166901
• Product Code: LRW
• UDI-Device Identifier: 00887482095379
• UDI-Public: 00887482095379
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: No Information
• Device Model Number: 57-2610
• Device Catalogue Number: 57-2610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1