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

Model Number 2030108

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

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.Rwmic will submit a follow up report with additional information and investigation of this complaint.

Event Description

On october 5th , 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the shaver handle stops during procedure, the unit says treatment mode and is not evacuating when it stops.Please check foot switch.They have used multiple shaver handles in one case and the same thing happened with different handles.It delayed the procedure by three hours, the patient had received two blood transfusions as a result.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.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? (only applicable if there was a report of delay) yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.

Manufacturer Narrative

User facility returned the device to rwmic on october 13, 2020, and currently rwmic is evaluating the device.Once the evaluation has been completed a follow up report will be submitted.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of the device.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

On october 5th, 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): piranha hand piece (suction pump) kept failing to activate, tried restarting unit but the hand piece would not work.Briefly switched to another hand piece and it only worked intermittently as well.Restarted unit 5 times, took 3 hours to do a 30 min procedure.The shaver handle stops during procedure, the unit says treatment mode and is not evacuating when it stops.Please check footswitch.They have used multiple shaver handles in one case and the same thing happened with different handles.It delayed the procedure by three hours, the patient had received two blood transfusions as a result.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.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? (only applicable if there was a report of delay) yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments is the importer of this device.No new information to provide.User facility was contacted three times in an effort to collect patient information and user information.As of 03/12/2021, rwmic has not received a response.Rwmic considers this mdr closed.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Labeling review (ga-a252):.The foot switch must not be actuated until "ready for use'' appears on the display of the typ 2208011, otherwise the error message "footswitch in use/ defective please check" appears, see ga-a252 chapter 5.7.1 and 7.1.Piranha mode or suction mode cannot be activated error "foot switch defective" check for correct tube connections, see ga-a252 chapter 7.I.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

Rwmic device evaluation (b)(6) 2021: the foot switch must not be actuated until "ready for use'' appears on the display of the typ 2208011, otherwise the error message "footswitch in use/defective please check" appears, see ga-a252 chapter 5.7.1 and 7.1.It is highly probable that the footswitch is actuated during vacuum buildup or that the vacuum is too low.Piranha mode or suction mode cannot be activated error "foot switch defective" check for correct tube connections, see ga-a252 chapter 7.I.Due to no fault could be found, no actions will be carried out.The reported condition could not be confirmed and no product failure could be identified.

• 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: 10692993
• MDR Text Key: 244131111
• Report Number: 1418479-2020-00031
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2030108
• Device Catalogue Number: 2030108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/06/2020; 01/19/2021; 01/19/2021
• Supplement Dates FDA Received: 11/03/2020; 02/02/2021; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other