MAUDE Adverse Event Report: SYMMETRY SURGICAL INC CODMAN DEBAKEY; MULTI-PURPOSE CLAMP

Model Number 37-1173

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing lot code on the device indicates that the device was manufactured in 2005.Upon evaluation of the returned instrument, it could not be confirmed that there was any aspect out of conformance.Based on the evalution of the device, it can be determined that the injury that occurred was not the result of a malfunction of the device.There has been a total of 195 sold since 2012 with no additional complaints recorded for this product.

Event Description

After the initial procedure, it was noticed there was a site of bleeding in the descending aorta which was complicated further by aortic injury requiring placement of an interposition graft.There was continued bleeding from all the suture sites.Therefore a covered stent was placed in the aorta.

Manufacturer Narrative

On 10/8/2020, additional information was provided by the end user that was not initially provided.The end user stated that the device scissorred when clamping the aorta, therefore damaging it during the initial procedure.Our evaluation of the product did not confirm this issue.The product functioned as intended with normal use.The device would only scissor with excessive force applied while torquing the device and purposefully making it scissor.As a result, there is no evidence that there are any defects in material or workmanship of the device.Therefore, no additional actions are necessary.

• Brand Name: CODMAN DEBAKEY
• Type of Device: MULTI-PURPOSE CLAMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10652490
• MDR Text Key: 210578482
• Report Number: 3007208013-2020-00028
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00887482011195
• UDI-Public: 00887482011195
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37-1173
• Device Catalogue Number: 37-1173
• Device Lot Number: 0512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention