MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) CUTTING ELECTRODE

Model Number 8426.132

Device Problems Separation Failure (2547); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

Actual device was returned to rwmic for evaluation on 02/25/2016.No evidence of arching was seen (no charring or melted areas) however, device was missing insulation and the metal tubing on the device was pulled over the area which is missing the insulation.It is the area between the missing insulation and the metal tubing where arching most likely occurred.The missing insulation and metal tubing moved from its proper placement was due to user mis-handling and not a manufacturing issue.Device was submitted stuck inside of another instrument.Unable to perform electrical testing due to device being stuck in the second instrument.Manufacturer date: 02/17/2015.Expiration date: 02/2020.Initial reporter has be contacted in an effort to gather missing information (ie patient information.), no response as of 03/15/2016.No similar complaints on this specific product has been reporter in the last three years.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Rwmic considers this matter closed.However, in the event additional information is received, rwmic will provide fda with follow-up information.

Event Description

Facility notified richard wolf medical instruments corporation (rwmic) that during a procedure device in question arched.Back up device readily available for use and procedure completed as scheduled.No injury to patient or staff reported.

Event Description

This report being submitted due to additional information received, follow up #1.

• Brand Name: CUTTING ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 5502872
• MDR Text Key: 40393494
• Report Number: 1418479-2016-00003
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: 8426.132
• Device Lot Number: 51003172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 74