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

Model Number 8680.224

Device Problem Sparking (2595)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Facility called richard wolf medical instruments corporation (rwmic) on (b)(6) 2014 indicating they are sending in device for repair, reporting it was making a noise.Once facility received cost estimate, facility notified rwmic sales rep the surgeon experienced a spark or shock while using device during the procedure, on (b)(6) 2014.Rwmic sales rep followed up with facility and on (b)(6) 2014 reported no shock occurred, only a spark.Complaint manager send out follow-up questions and on (b)(6) 2014 received email indicating during procedure doctor heard a noise that he believes came from the device and the noise may have been a spark.No injury to pt or staff reported.Slight delay in procedure as doctor switched to a back up monopolar system.Mfr date on: 03/2012.Last in for repair/maintenance: none on file.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Investigation found broken parts in device due to wear and tear.No record of device for routine maintenance or repair.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 info, we will provide fda with follow-up info.User facility: (b)(6).

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC); vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3829774
• MDR Text Key: 4391741
• Report Number: 1418479-2014-00015
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2014

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: 65M12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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