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

Model Number 8424.141

Device Problems Hole In Material (1293); Arcing of Electrodes (2289); Component Missing (2306); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

Actual device returned to richard wolf medical instrumentation corporation (rwmic) for investigation on (b)(6) 2015.Device missing approximately 15mm of insulation from distal end of electrode, appears to have been cut.Device was sent in with the sheath that was being used during the time of the issue.The sheaths ceramic tip had pieces broken off from the distal tip leaving sharp ends which could have cut the insulation from this device.This device was tested with hypot tester and no electrical short found.Requests for missing/additional information have been submitted, no response as of (b)(6) 2015.Manufacture date: 04/07/2015.Purchase date: (b)(6) 2015.No similar issues on this device on the last three years.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions regarding high temperatures and use of irrigation fluid.Rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to fda.

Event Description

Facility reported to one of richard wolf medical instruments corporation (rwmic) customer repair specialist that a device arched and damaged the tip of a second device being used during the procedure.The two impacted devices were swapped out to back up devices, readily available for use, and procedure was completed as scheduled.No injury to patient or staff reported.At least six devices are assembled together in order to operate.The two devices which had product problems and their associated mdr's are: sheath (8661.3741) - mdr 1418479-2015-00031 (tip damaged).Electrode (8424.141) - mdr 1418479-2015-00032 (device arched).

Manufacturer Narrative

Rwmic received additional information from user facility.

• 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: 5124528
• MDR Text Key: 27376180
• Report Number: 1418479-2015-00032
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8424.141
• Device Catalogue Number: 8424.141
• Device Lot Number: 51003398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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: 77 YR
• Patient Weight: 111