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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH FOOTSWITCH 2 PEDALS MOTOR CONTROL UNIT 2304

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RICHARD WOLF GMBH FOOTSWITCH 2 PEDALS MOTOR CONTROL UNIT 2304 Back to Search Results
Model Number 2304901
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
Event Type  Injury  
Manufacturer Narrative
The manufacturer has been contacted. Rwmic considers this mdr open. Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
 
Event Description
It was reported to richard wolf: "(b)(6) called (b)(6), the local rep, during the procedure. When the footswitch for the power drive art1 was activated, the controller displayed a "foot pedal defective" error message. The rep asked them to disconnect and re-connect the footswitch, and the message was no longer displayed. When they started the procedure, the handpiece wasn't rotating the burr. They disconnected the cable from the handpiece and generator, and re-connected. The handpiece still would not rotate the burr. Then the rep called me to conference with the operating room, and that's when the physician stopped the case. He had made an incision, stopped the case, closed the incision, and will re-schedule. (b)(6), the local sales rep went to the account and determined that the (2) 89955. 0000 m4 motor handpieces and the 8564. 851 connecting cable were functioning properly, and will not be returned to us for evaluation. " will the device be returned? yes. Was the device being used on a patient when the reporting issue occurred? yes. Was there any injury or illness to the patient due to the reported issue? no. Was there any injury or illness to any other personnel due to the reported issue? no. Did the issue cause a delay in the procedure being performed? yes. Did the delay put the patient at risk? yes. Was there a similar back-up device available for use? no. Was the scheduled procedure completed? yes.
 
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Brand NameFOOTSWITCH 2 PEDALS
Type of DeviceMOTOR CONTROL UNIT 2304
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimerstr. 32
knittlingen 75438
GM 75438
MDR Report Key13543532
MDR Text Key290391888
Report Number1418479-2022-00007
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/29/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2304901
Device Catalogue Number2304.901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2022
Distributor Facility Aware Date02/02/2022
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer07/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
Treatment
BURR; CONNECTING CABLE8564.851; POWERDRIVE ART1 GENERATOR2304.007; POWERSTICK M5/089955.0000
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