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

Model Number	37-1173
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MULTI-PURPOSE CLAMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10652490
• Report Number: 3007208013-2020-00028
• Device Sequence Number: 3529430
• Product Code: DXC
• UDI-Device Identifier: 00887482011195
• UDI-Public: 00887482011195
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention