MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. CLASSIC PLUS; NEEDLE HOLDER

Model Number 36-2002

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

User facility did not provide symmetry surgical with the device part number, not knowing what device was involved.Symmetry could not report within the 30 timeframe.

Event Description

Needle holder insert fell of during surgery.

• Brand Name: CLASSIC PLUS
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5221768
• MDR Text Key: 31755954
• Report Number: 3007208013-2015-00029
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 00887482009642
• UDI-Public: 00887482009642
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 36-2002
• Device Catalogue Number: 36-2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1