MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	46531313
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the loop (wire part) noted missing, may have disintegrated.

• Brand Name: PRINCESS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 15645289
• Report Number: 15645289
• Device Sequence Number: 2530390
• Product Code: FAS
• UDI-Device Identifier: 04055207050101
• UDI-Public: (01)04055207050101
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/05/2022
• Report Date (Section F): 10/05/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 10/05/2022