MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) WORKING ELEMENT

Model Number 8680.224

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

Two different individuals from the same facility reported two different events on the device in question.First report, device was bent and almost broke in half during cleaning process.Not being used on a patient, no delay in procedures placing a patient at risk.Second report, device bent during a procedure.No injury to patient reported.Device received in one piece but bent at an almost 90 degrees angle.Mechanical assembly manager found the shaft was bent.Appears device was bent by coming into contact with a drawer or similar hard container.Root cause is due to handling.Device purchased: (b)(6) 2009.Last in for repair/maintenance: (b)(4) 2011.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.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 additional information, we will provide fda with follow-up information.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC); vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3821172
• MDR Text Key: 4450112
• Report Number: 1418479-2014-00016
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/07/2014

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: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: 65A09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1