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

Model Number	2208011
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a suction pump, part id: 2208011, serial # (b)(6).According to the user facility, "the unit would not create suction." after trying to troubleshoot the pump issue, the doctor called off the surgery.In addition, the reported issue caused a 10 minute delay during the holep procedure while they tried to resolved the reported issue.There was no back-up device available and the scheduled procedure was not completed.There is no report of injury to the patient or other personnel.

• Brand Name: PIRANHA
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17445861
• Report Number: 9611102-2023-00051
• Device Sequence Number: 11456459
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown