MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY® CLAMP; CLAMP, CHOLANGIOGRAM

Model Number	91-5035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device showed significant signs of use, instrument wore down due to normal wear and tear.
Event or Problem Description
Hospital had a cholangiogram forceps tip break during the surgical procedure.

• Brand Name: SYMMETRY® CLAMP
• Common Device Name: CLAMP, CHOLANGIOGRAM
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7521805
• Report Number: 3007208013-2018-00008
• Device Sequence Number: 16380057
• Product Code: GEN
• UDI-Device Identifier: 00887482129777
• UDI-Public: 00887482129777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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 Model Number: 91-5035
• Device Catalogue Number: 91-5035
• Device Lot Number: BJ1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1