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

Model Number 2208011

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  Injury  

Event 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 morcellation pump wasn't able to build enough suction to allow morcellation.In addition, the reported issue caused a delay in the middle of morcellating the prostate during the holep procedure.The patient had to be catheterized over the weekend.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
• Type of Device: 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: 17664730
• MDR Text Key: 322472471
• Report Number: 9611102-2023-00053
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other