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

Model Number	2208011
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
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 received information, the suction pump failed to provide sufficient suction.The reduction in suction has been noticed by a health professional on procedures with larger prostates (over 150 grams) after the initial canister change during morcellation, with both the tissue trap and bacteria filter are changed each time a canister change takes place.The issue has been noted over the last few months of procedure.In addition, the healthcare professional noted there is no reduction in suction on procedures with smaller prostates and no canister changes.
Additional Manufacturer Narrative
The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h11.The suction pump was investigated and determined that the o-ring on the vacuum connection is missing.The cause can be attributed as a user error.Nevertheless, the fault could easily be detected if the instructions for use are followed correctly.The suction pump, 2208011 with the serial number (b)(6) was manufactured on 09/29/2022.No issue was identified during production.No further complaints were received for this serial number.The instructions for use, ifu "ga-a 252-usa /en/ 2012-07 v2.0 / pdg 11-5360" contains several important notes regarding "loose or damage parts" in section 4 checks.A malfunction of the product/product components leading to "chemical hazards/additional anaesthetics" due to an application error (the user does not identify possible defects in the system/system components) is listed in risk management file e3-1: suction pumps with accessories, v00.The overall probability of occurrence of this problem remains at the previously defined level and the overall risk of the device remains in the acceptable category.

• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20348473
• Report Number: 9611102-2024-00033
• Device Sequence Number: 15459915
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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
• Patient Sex: Unknown