MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8680.224

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Hearing Loss (1882); Electric Shock (2554)

Event Type  Other  

Event Description

Richard wolf medical instrument corporation (rwmic) was notified by one of its sales representatives that during a bipolar turp procedure, one of the nurses touched the head of the pt and was shocked.Nurse reported losing hearing for a while.No injury to pt, was reported.Three possible suspect devices below were being used at the time of the incident, they consist of the following: bipolar cable (id# (b)(4)) report 1418479-2014-00049.Working element (id# (b)(4)) report 1418479-2014-00050.Generator (id# (b)(4)) report 1418479-2014-00051.Facility: (b)(6).

Manufacturer Narrative

An investigation has not been completed, actual devices are in transit to the rwmic facility, rwmic will then send devices to manufacture for investigation.A request for additional info has been submitted to facility, no response as of 11/21/2014.Richard wolf medical instruments corporation considers this matter closed.However, in the event we receive additional info, we will provide manufacturer/fda with follow-up info.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; GM
• MDR Report Key: 4321061
• MDR Text Key: 16847896
• Report Number: 1418479-2014-00050
• 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: 11/21/2014,10/22/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2014
• Distributor Facility Aware Date: 10/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other