MAUDE Adverse Event Report: PROSURG INC SALINETRODE FLEX; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number 3.0F60S BALL

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

While using the flexible bipolar electrode during a ventriculostomy procedure, a wire at the end of the electrode appeared to unravel from the tip.The surgeon also noticed that the electrode was not working as before.

• Brand Name: SALINETRODE FLEX
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): PROSURG INC; 2193 trade zone blvd.; san jose CA 95131
• MDR Report Key: 9097485
• MDR Text Key: 159346692
• Report Number: 9097485
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

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 Catalogue Number: 3.0F60S BALL
• Device Lot Number: 0619012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 480 DA