MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; CONNECTION CABLE

Model Number	2208121
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments is the importer of this device.User facility was contacted three times in an effort to collect patient information and user information.As of 03/9/2021 rwmic has not received a response.There is no new information to add at this time.Rwmic considers this mdr closed.
Event or Problem Description
Rwmic device evaluation 01/27/2021: findings: according out test instruction pao 1-001-8914 no failure found.During the inspection of the connecting cable type 2208121 no defect/error could be detected.The foot switch type 2030 i 08 must not be actuated until "ready for use" appears on the display of the type 2208011, otherwise the error message "footswitch in use/ defective please check" appears, see ga-a252 chapter 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.Due to no fault could be found, no actions will be carried out.The reported conditions could not be confirmed.
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.Labeling review (ga-a252): the foot switch typ 2030 i 08 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 7.1.Piranha mode or suction mode cannot be activated error "foot switch defective" check for correct tube connections.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.

• Brand Name: PIRANHA
• Common Device Name: CONNECTION CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10779271
• Report Number: 1418479-2020-00041
• Device Sequence Number: 1138099
• Product Code: JCX
• UDI-Device Identifier: 04055207064061
• UDI-Public: 04055207064061
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2208121
• Device Catalogue Number: 2208121
• Device Lot Number: WSB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 01/19/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 02/02/2021; 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other