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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Granuloma (1876); Necrosis (1971)

Event Date 07/15/2020

Event Type  Injury  

Event Description

Bekki t, yamamoto y, saeki y, arihiro k, tanabe k, ohdan h.Iatrogenic hepatic granuloma (suspected liver metastatic lesion on imaging) caused by liver retraction during laparoscopic gastrectomy: a case report.Clin case rep.2020;00:1¿5.Description of procedure + malfunction/injury as outlined below: patient was diagnosed with advanced gastric cancer ; patient underwent laparoscopic total gastrectomy; total inoperative liver retraction time was 157 minutes; post-operative results showed elevated liver enzymes (liver dysfunction); post-operative follow-up at 2 weeks showed abnormalities in the low density area of the liver.Partial hepatectomy at 2 months post-operation revealed epithelioid granuloma with coagulation necrosis.Authors hypothesize that granuloma formation was the result of intraoperative liver retraction using the nathanson during laparoscopic gastrectomy.Subsequent follow-up show no re-occurrence.

Event Description

Bekki t, yamamoto y, saeki y, arihiro k, tanabe k, ohdan h.Iatrogenic hepatic granuloma (suspected liver metastatic lesion on imaging) caused by liver retraction during laparoscopic gastrectomy: a case report.Clin case rep.2020;00:1¿5.Description of procedure + malfunction/injury as outlined below: patient was diagnosed with advanced gastric cancer.Patient underwent laparoscopic total gastrectomy.Total inoperative liver retraction time was 157 minutes.Post-operative results showed elevated liver enzymes (liver dysfunction).Post-operative follow-up at 2 weeks showed abnormalities in the low density area of the liver.Partial hepatectomy at 2 months post-operation revealed epithelioid granuloma with coagulation necrosis.Authors hypothesize that granuloma formation was the result of intraoperative liver retraction using the nathanson during laparoscopic gastrectomy.Subsequent follow-up show no reoccurrence.

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.Clinical evidence report for the nathanson liver retractor system' was reviewed as part of this investigation.The report states that the nathanson liver retraction system is a surgically invasive device contacting body tissues and fluids, adverse events associated with its use are related to liver injury or damage.The ifu sent with the complaint device contain specific instructions regarding dimensions and instructions for insertion.Based on the information received the exact root cause or cause of failure could not be determined.

• Brand Name: NATHANSON LIVER RETRACTOR
• 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: 10999289
• MDR Text Key: 221239057
• Report Number: 9680654-2020-00041
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR