MAUDE Adverse Event Report: POWER CONTROL; MOTOR CONTROL UNIT 2303

Model Number	2303011
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility and manufacturer will be contacted for additional information.Upon receipt of new information, a follow-up report will be submitted.
Event or Problem Description
It was report to rw mic on (b)(6) 2020 that the piranha power control unit.The loaner #1 unit that vanderbilt is sending back had issues with the control unit freezing up.When i would unplug the communication cable to adjust the blade, the tool would appear but not the double arrow button.I had to turn the unit off and back on to get the arrow button to pop back up.Richard wolf clinical specialist that submitted the complaint, also report that the unit i have here at the house did the same thing the other day.So i was taking a video of this to show you guys what it was doing.I will send you the video.On the video you will notice a brown speck above the footswitch symbol.That speck was inside the unit heating up but i did not even notice the spot until after my hand touched it and it was real hot.It then lit up and almost caught on fire.This incident will be filed under mdr report 1418479-2020-00025.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation.Rw gmbh received and evaluated the device.The device was functionally, visually and mechanically evaluated.The reported condition was not confirmed.The device was checked, no errors found.No actions were taken.The device met specifications.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Rwmic considers this mdr closed.Rwmic will submit a follow-up report if new information becomes available.

• Brand Name: POWER CONTROL
• Common Device Name: MOTOR CONTROL UNIT 2303
• MDR Report Key: 10538489
• Report Number: 1418479-2020-00023
• Device Sequence Number: 19798365
• Product Code: HRX
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K030082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Other
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUCTION PUMP: P/N: 2208011, S/N: (B)(6)