MAUDE Adverse Event Report: AESCULAP AG PITUITARY RONGEUR-3MM, STAINLESS

Model Number FF805R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2023

Event Type  Injury  

Event Description

Pituitary rongeur broke during l5-s1 microdiscectomy.Broken piece was recovered from the wound and it was exact match with broken instrument.A portable x-ray was taken which says- "no radiopaque foreign body".Patient was extubated and brought to pacu.No other complications.Pt was stable and discharged home the same day.

• Brand Name: PITUITARY RONGEUR-3MM, STAINLESS
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG
• MDR Report Key: 16953791
• MDR Text Key: 315549675
• Report Number: MW5117648
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF805R
• Device Catalogue Number: 6AOGY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 101 KG