MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8653.224

Device Problem Use of Device Problem (1670)

Patient Problems Flashers (1864); No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Customer called richard wolf medical instruments corporation (rwmic) on (b)(6) 2014 and reported at the end of a procedure, device sparked and smoke was seen.No injuries to pts or staff was reported.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(6) 2013.Device history: manufactured 09/2010, sold on (b)(6) 2011, no record of any repairs or routine maintenance of device.No unusual findings, normal wear and tear of parts found on 3 1/2 yr old device.If moisture were to get in lock housing a spark may occur.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 add'l info, we will provide fda with f/u info.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; knittlingen 75438 ; GM 75438
• MDR Report Key: 3736437
• MDR Text Key: 20711426
• Report Number: 1418479-2014-00012
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014,02/28/2014

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: 8653.224
• Device Catalogue Number: 8653.224
• Device Lot Number: 1109941
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2014
• Distributor Facility Aware Date: 02/28/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1