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

Model Number 46531313

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

Richard wolf medical instruments corporation is the importer of this device.Rwmic will notify rwgmbh (manufacturer) if new information becomes available.

Event 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
• Type of Device: CUTTING ELECTRODE BIPO 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15760347
• MDR Text Key: 303337251
• Report Number: 1418479-2022-00031
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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
• Date Report Sent to FDA: 11/09/2022
• Distributor Facility Aware Date: 10/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White