MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD NATHANSON LIVER RETRACTOR EXTRA LARGE; GAD RETRACTOR - MURDOCH MECHANICAL ARM

Catalog Number NLRS-1002

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

Patient Problems Liver Damage/Dysfunction (1954); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

This event was identified in the following paper: a novel liver retraction method in laparoscopic gastrectomy for gastric cancer (cea25022_revision 004).(b)(6) noted that the use of a nathanson retractor is an independent risk factor for elevated liver enzymes.

Event Description

This event was identified in the following paper: a novel liver retraction method in laparoscopic gastrectomy for gastric cancer (cea25022_revision 004).The department of surgery, internal medicine, research institute for covergence of biomedical science and technology, pusan national university yangsan-si hospital, korea noted that the use of a nathanson retractor is an independent risk factor for elevated liver enzymes.

Manufacturer Narrative

The device was not returned for evaluation.The lot number was not supplied, and therefore a review of the device history record could not be performed.The device ifu states: - step 4: under direct laparoscopic vision, manoeuvre the curved edge of the nathanson liver retractor in a superior direction under the left lobe of the liver.- step 5: continue placement of the ports.When this is complete, attach the nathanson liver retractor to the retractor arm and elevate the liver to the desired position.Periodic release of the retractor pressure may be necessary throughout the procedure to minimise the risk of hepatic ischaemia.Based on the information provided in it can be concluded that the adverse effect of the patient was most likely caused by a combination of patient-related factors, procedural-related factors, and insufficiently following the ifu.

• Brand Name: NATHANSON LIVER RETRACTOR EXTRA LARGE
• Type of Device: GAD RETRACTOR - MURDOCH MECHANICAL ARM
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 8376192
• MDR Text Key: 137364385
• Report Number: 9680654-2019-00007
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: NLRS-1002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other