MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8653.224

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 facility contacted richard wolf medical instruments corporation (rwmic) indicating they would like to send in their working elements for "evaluation." in an e-mail, dated (b)(6) 2014, discussing working elements in general, facility mentioned an incident where a spark occurred on (b)(6) 2014.It appears the instrument in question was one of the working elements sent in for evaluation.Facility indicated no injury to patient or staff occurred.In addition, no delay in a procedure placing a patient at risk was reported.A few parts on device were replaced due to being loose and/or worn out.Purchase date: 10/2011, no record of any routine maintenance or repairs.An investigation was completed as the actual device was returned on (b)(4) 2014.A few parts on device were replaced due to being loose and/or worn out.Device history: purchased 10/2011, no record of any routine maintenance or repairs.If moisture or liquid were to get in lock housing, a spark may occur (i.E.Device not completely dried after reprocessing or from saline during use due to worn o-ring).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
• MDR Report Key: 3854262
• MDR Text Key: 20456541
• Report Number: 1418479-2014-00026
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/29/2014,04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• 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
• Device Lot Number: 1116177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 04/30/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1