MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM

Model Number	49700103
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the holep surgery, four (4) morcellator blades failed to rotate and therefore, unable to provide suction.The first blade worked for 10 minutes then locked up and the blades after that locked up as well upon testing them before inserting them into the patient.The user tried to replaced the tubing and the container, however, failed to get the blades to function.Due to the reported issue, the scheduled procedure was cancelled as well as the succeeding cases.There were no reports of injuries to the patient or third party.
Additional Manufacturer Narrative
The reporter has also reported that the handpiece device worked fine.Richard wolf medical instruments corporation (rwmic - importer) has initiated four complaints, one for each suspected morcellator blade.These are complaints: (b)(4) respectively.Since all four suspected morcellation blades were reported from the same facility and concerns the same device, the same batch number, and the same planned procedure, richard wolf gmbh (rw gmbh-manufacturer) has determined to submit a single report that covers all four morcellation blades.

• Brand Name: PIRANHA
• Common Device Name: ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM
• 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: 23006566
• Report Number: 9611102-2025-00046
• Device Sequence Number: 9711263
• Product Code: FJL
• UDI-Device Identifier: 04055207063415
• UDI-Public: 04055207063415
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/09/2025

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: 49700103
• Device Catalogue Number: 49700103
• Device Lot Number: 1604202501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown