MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. WORKING ELEMENT

Model Number 8680.224

Device Problem Device Stops Intermittently (1599)

Patient Problem No Code Available (3191)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Device worked on and off during procedure.No injury to patient or staff reported; however, case was stopped and rescheduled for a later date.Two devices with the same lot number were in or room but only one was used, the other returned for evaluation.Mdr report completed for both devices.Mdr 1418479-2014-00010, mdr 1418479-2014-00011.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Mechanical assembly manager found the shaft was bent, most likely due to handling over time.No issues found to cause device to start and stop functioning.Device last in for repair and/or maintenance on 06/13/2012.Device was used in conjunction with a competitor's generator and bipolar cable.Rwmic instruction manual indicates "use the product only in the combinations and with the accessories and spare parts specified in this instruction manual," and this competitor's devices are not listed in the manual.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Richard wolf considers this matter closed; however, in the event we receive additional information, we will provide the fda with follow-up information.

• Brand Name: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3850772
• MDR Text Key: 4406727
• Report Number: 1418479-2014-00011
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2014

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: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: M1011047
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1