MAUDE Adverse Event Report: AESCULAP AG AESCULAP; RONGEUR

Model Number FF803R

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

Pituitary instrument tip broke off while in use during procedure.Surgeon found tip and both pieces were removed from field.Portable x-ray taken in operating room prior to count.No mental fragments confirmed by reading room.

• Brand Name: AESCULAP
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 10704600
• MDR Text Key: 212101821
• Report Number: 10704600
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1