MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8653.224

Device Problems Sparking (2595); Device Operates Differently Than Expected (2913)

Patient Problems Flashers (1864); No Consequences Or Impact To Patient (2199); Fibrosis (3167)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

Facility contacted one of richard wolf medical instrument corp (rwmic) sales reps to report that a spark was seen during a procedure to remove a fibroid from pt's uterus.No injury to pt or staff reported.

Manufacturer Narrative

An investigation was not completed as the actual device was not returned for investigation as of 10/09/2014.Facility indicated they will not be returning device but will help in providing add'l info and photos.Device history: unk at this time, serial number not given.According to rwmic records, six devices of one lot were purchased 09/2008 and one add'l device purchased 10/2009.Richard wolf considers this matter opened.Once add'l info is received, f/u info will be provided to fda.

Event Description

This is a follow up report to change status of this report from open to closed, no new information added.If any additional information is received it will be forwarded to manufacture.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; knittlingen 75438 ; GM 75438
• MDR Report Key: 4193997
• MDR Text Key: 4980398
• Report Number: 1418479-2014-00044
• 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,unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2014,09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2014
• Distributor Facility Aware Date: 09/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1