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

Model Number 46531313

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The tip of the loop (wire part) noted missing, may have disintegrated.

• Brand Name: PRINCESS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 15645289
• MDR Text Key: 302166975
• Report Number: 15645289
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207050101
• UDI-Public: (01)04055207050101
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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 Sent to FDA: 10/05/2022
• Date Report to Manufacturer: 10/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Race: White