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

Model Number	2208011
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, the suction pump failed to provide sufficient suction during a procedure.Although no injuries were reported, the user reports that the planned treatment could not be completed after a one-hour delay due to troubleshooting attempts and that no back-up device was available.The facility reported that they ended up having to cath patient with tissue left behind.

• 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: 23360331
• Report Number: 9611102-2025-00055
• Device Sequence Number: 8964571
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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 Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2303.011 - MOTOR CONTROL UNIT 2303SN# (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown