MAUDE Adverse Event Report: BECTON DICKINSON GMBH/CAREFUSION BD SNOWEN PENCER, USA LAPAROSCOPIC LIVER RETRACTOR (SNAKE RETRACTOR); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number L18 89-6112

Device Problems Unraveled Material (1664); Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 01/30/2019

Event Type  Injury  

Event Description

Patient undergoing laparoscopic paraesophageal hernia repair on (b)(6) 2019.Left lobe of the liver was retracted laterally to the right.In doing this, the retractor was noted to suddenly unwind partially and resulted in a perforation of the left lobe of the liver.On removal no parts appeared to be missing, but it was bent in an unusual position.Bleeding controlled, completed with no permanent harm to patient.

• Brand Name: BD SNOWEN PENCER, USA LAPAROSCOPIC LIVER RETRACTOR (SNAKE RETRACTOR)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BECTON DICKINSON GMBH/CAREFUSION
• MDR Report Key: 8392233
• MDR Text Key: 137953515
• Report Number: MW5084636
• Device Sequence Number: 0
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L18 89-6112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR