MAUDE Adverse Event Report: ARTISAN MEDICAL SNAKE LIVER RETRACTOR 5MM

Model Number SNK-100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Event Description

The snake retractor "become" stuck in the coiled position and had to be manually manipulated through the laparoscopic port inserted in the patient.No harm to patient.

• Brand Name: SNAKE LIVER RETRACTOR 5MM
• Type of Device: RETRACTOR
• Manufacturer (Section D): ARTISAN MEDICAL; 27 wakefield dr; medford NJ 08055
• MDR Report Key: 7955454
• MDR Text Key: 123371779
• Report Number: 7955454
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2018,05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SNK-100
• Device Catalogue Number: SNK-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA