MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; SUCTION PUMP

Model Number 2208011

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 gmbh.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): 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 (follow-up report #2) 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.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.The following sections include new or changed information: b4, b5 g3, g6, h2, h3, h6, and h10.Labeling review (ga-a252): important! if you cannot eliminate the fault with the help of this table, please contact the service department or return the device for repair.' do not attempt to do any repairs yourself! important! work only at the recommended speed setting and under constant irrigation.If the speed setting is too high or if operated without irrigation the internal blade can seize or wear rapidly or clog if the speed setting is too low.A suction channel clogged by tissue parts will impair morcellation.Clean clogged suction channel with a suitable cleaning brush.Keep a spare rotary morcellator ready for each use.Caution! the products have only limited strength! exerting excessive force may lead to damage, impair the function and therefore endanger the patient.Check the products for damage, loose parts and completeness immediately before and after each use.Make sure no missing instrument parts remain in the patient.Do not use products that are damaged, incomplete or have loose parts.Rwmic considers this mor/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

Rwmic device evaluation 01/27/2021: findings: according out test instruction pao 1-001-8914 no failure found.During the inspection of the suction pump 2208011 no defect/error could be detected.The foot switch type 2030108 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 further actions will be carried out.

• Brand Name: PIRANHA
• Type of Device: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10779249
• MDR Text Key: 229366133
• Report Number: 1418479-2020-00040
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• 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
• 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: 2208011
• Device Catalogue Number: 2208011
• 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: 11/03/2020
• Supplement Dates Manufacturer Received: 01/19/2021; 01/19/2021
• Supplement Dates FDA Received: 02/02/2021; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other