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

Model Number	2208011
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the suction pump failed to provide sufficient suction during the morcellation of prostate (holep) procedure.The user reported that there was a 30 minute delay in the procedure.There was no similar back-up device, and the remaining tissues had to be basketed out.The procedure was completed without additional medical treatment.All the other devices used with the suction pump were working properly.
Additional Manufacturer Narrative
The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), and h11.The suction pump, 2208011, was examined in the specialist department.The suction function is fine, as is the vacuum build-up.According to the examination report, the inside of the socket for the foot switch is not as it should be.The notch is twisted 90°· to the right and broken.It is possible that the foot switch 1 pedal, 2030108, was inserted incorrectly and therefore did not trigger the suction.The cause is due to mechanical overload, probably caused by excessive force being applied during use.The suction pump type 2208011 with the serial number (b)(6), was manufactured on 29th march 2023.No abnormalities were found during production, all devices passed the functional checks.Richard wolf gmbh has received several complaints in the past 2 years.The complaints either show customer faults due to operating error, or sporadic failure or wear and tear outside the warranty period, or damage due to mechanical influences, as well as no functional error on the device.As the review of all available data does not show signs of systematic errors or a trend, no further action is necessary.In our risk analysis e3-1: v00, suction pumps with accessories, manufacturing-related, handling-related and design­related hazards regarding functional impairment as well as risks due to a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.

• Brand Name: PIRANHA
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21452907
• Report Number: 9611102-2025-00006
• Device Sequence Number: 7761719
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TYPE 2030108 FOOTSWITCH 1 PEDAL.; TYPE 2303.011 MOTOR CONTROL UNIT 2303.; TYPE 8564.021 MOTOR HANDPIECE MAX. 6000RPM.
• Patient Sex: Unknown