MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8653.224

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

Facility e-mailed richard wolf medical instruments corporation (rwmic) on (b)(6) 2014 and reported while preparing for a procedure, prior to use, device sparked on the hand piece.Device was not being used on a patient and no injuries to staff were reported.In addition, no delay in a procedure placing a patient at risk was reported.Facility also called rwmic technical support representative confirming information above.Facility mention not a "complaint" but an investigation on their end.Above facility sent rwmic a similar device, same model number, for repair on (b)(4) 2014 indicating it was missing a screw.Facility indicated device not being used on patient.It is unknown if this is the device that had sparked.A few items (screw, socket, jointed section and thumb ring) on this device were replaced due to item being loose, worn or missing.

Manufacturer Narrative

An investigation was not completed as the actual device was not returned for investigation.Device history: unknown, serial number not given.If moisture were to get in lock housing, a spark may occur.(i.E.Device not completely dried after reprocessing or from saline during use).Labeling was reviewed and found to be adequate.(i.E.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 fda with follow-up information.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: 353 corporate woods pkwy.; vernon hills, IL 60061
• MDR Report Key: 3788331
• MDR Text Key: 4434928
• Report Number: 1418479-2014-00017
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/29/2014,03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• 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: 04/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1