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U.S. Department of Health and Human Services

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

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RICHARD WOLF MEDICAL INSTRUMENTS CORP. WORKING ELEMENT Back to Search Results
Model Number 8680.224
Device Problem Device Stops Intermittently (1599)
Patient Problem No Code Available (3191)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
Device worked on and off during procedure.No injury to patient or staff reported; however, case was stopped and rescheduled for a later date.Two devices with the same lot number were in or room but only one was used, the other returned for evaluation.Mdr report completed for both devices.Mdr 1418479-2014-00010, mdr 1418479-2014-00011.
 
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 was bent, most likely due to handling over time.No issues found to cause device to start and stop functioning.Device last in for repair and/or maintenance on 06/13/2012.Device was used in conjunction with a competitor's generator and bipolar cable.Rwmic instruction manual indicates "use the product only in the combinations and with the accessories and spare parts specified in this instruction manual," and this competitor's devices are not listed in the manual.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 the fda with follow-up information.
 
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Brand Name
WORKING ELEMENT
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills IL 60061
Manufacturer Contact
dawn clark
353 corporate woods pkwy.
vernon hills, IL 60061
8479558016
MDR Report Key3850772
MDR Text Key4406727
Report Number1418479-2014-00011
Device Sequence Number1
Product Code FDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/20/2014
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 Number8680.224
Device Catalogue Number8680.224
Device Lot NumberM1011047
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2014
Initial Date FDA Received03/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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