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; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 23360266
• Report Number: 1418479-2025-00012
• Device Sequence Number: 8797552
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2025
• Device Age: 16 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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: 2303.011 - MOTOR CONTROL UNIT 2303SN# (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/22/2025