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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTORIZED HANDLE; POWER STICK
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RICHARD WOLF GMBH MOTORIZED HANDLE; POWER STICK Back to Search Results
Model Number 8564.021
Device Problems Complete Blockage (1094); Decrease in Suction (1146)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2014
Event Type  malfunction  
Event Description
Richard wolf medical instrument corporation (rwmic) sales rep reported that during a case there was no suction through the device in question.Surgeon went to manual method and retrieved tissue and this caused a delay in procedure that may have placed pt at risk.No injury to pt or staff reported.
 
Manufacturer Narrative
An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Device rec'd very dirty, many washes and flushes required to clean.Electronic dept found no issues with device.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 add'l info, we will provide fda with f/u info.
 
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Brand Name
MOTORIZED HANDLE
Type of Device
POWER STICK
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer strasse 32
GM 
MDR Report Key3787270
MDR Text Key4430891
Report Number1418479-2014-00014
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 04/25/2014,03/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8564.021
Device Catalogue Number8564.021
Device Lot Number1100157009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2014
Distributor Facility Aware Date03/19/2014
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/25/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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