MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP KERRISON RONGEUR WITH A THIN FOOTPLATE; RONGEUR, NASAL

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Kerrison bending during use, making it difficult to do the procedure.Had to switch out to a different instrument.

• Brand Name: AESCULAP KERRISON RONGEUR WITH A THIN FOOTPLATE
• Type of Device: RONGEUR, NASAL
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 18885975
• MDR Text Key: 337439490
• Report Number: 18885975
• Device Sequence Number: 1
• Product Code: KBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 11/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1