MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; FOOTSWITCH 1 PEDAL FOR PIRANHA SUCTION PUMP

Model Number 2030108

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.The user facility and manufacturer will be contacted for additional information.Upon receipt of new information, a follow-up report will be submitted,.

Event Description

On august 31st, 2020, the clinical specialist reported the following to richard wolf medical instruments corporation (rwmic): i wanted to give you some information regarding the piranha power control unit.The loaner #1 unit that (b)(6) 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.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.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? no.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? n/a.Did the delay put the patient at risk? (only applicable if there was a report of delay) n/a.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? n/a.The initial report for the power controller (2303011) was reported under mdr# 1418479-2020-00025 on (b)(6) 2020.However, this report is for the additional product (footswitch) which was used with the reported power controller.

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.Missing information: there are no patient details, the device was not being used on a patient at the time.Changed information: g4 - this is not a combination product (error from initial report).Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device evaluation/investigation.The device was received and visually, functionally and electrically evaluated.The reported condition was not confirmed.The device was checked, no errors were found.

• Brand Name: PIRANHA
• Type of Device: FOOTSWITCH 1 PEDAL FOR PIRANHA SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10803466
• MDR Text Key: 246057420
• Report Number: 1418479-2020-00027
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04055207054734
• UDI-Public: 04055207054734
• Combination Product (y/n): Y
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 2030108
• Device Catalogue Number: 2030108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1