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

Model Number 8680.224

Device Problem Inadequate Service (1564)

Patient Problems Flashers (1864); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

During procedure, device arched to resectoscope.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Mechanical assembly manager found the shaft lock housing was badly damaged beyond repair, most likely due to wear and tear and handling over time.Device history: manufacture date - 10/2009; purchase date - (b)(4) 2010; repair dates - (b)(4) 2011 and (b)(4) 2012.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 received additional information, we will provide the fda with follow-up information.User facility: (b)(6).

• 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: 3839247
• MDR Text Key: 4412409
• Report Number: 1418479-2014-00001
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: 1073113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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