MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPO 21FR

Model Number	46531313
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is the importer of this device.Rwmic will notify rwgmbh (manufacturer) if new information becomes available.
Event or Problem Description
Rwmic reference complaint no.(b)(4).On october 20, 2022, richard wolf medical instruments corp.(rwmic) received a medsun mandatory and voluntary report # 2211900000-2022-8008 regarding product id# 46531313, lot#21003675.Description of event: the tip of the loop (wire part) noted missing, may have disintegrated.Currently, requests for additional information from the user facility have been unsuccessful.Rwmic mdr awareness date: 20-oct-2022.

• Brand Name: PRINCESS
• Common Device Name: CUTTING ELECTRODE BIPO 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15760347
• Report Number: 1418479-2022-00031
• Device Sequence Number: 20888298
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2022
• Report Date (Section F): 11/09/2022

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
• Device Model Number: 46531313
• Device Catalogue Number: 46531313
• Device Lot Number: 21003675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2022
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 11/09/2022