MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG FEHLING CE 2MM NLU-2; PITUITARY RONGEUR

Model Number CE 2MM NLU-2

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2017

Event Type  malfunction  

Event Description

Cervical fehling broke during surgery noticed in css.Physician notified.Saw small metal on x-ray.Got ct scan.Confirmed metal retained.Opened pt at the bedside.Replaced piece of broken fehling.Smaller than piece missing.Add'l x-rays.No other metal seen.

• Brand Name: FEHLING CE 2MM NLU-2
• Type of Device: PITUITARY RONGEUR
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH & CO. KG; GM
• MDR Report Key: 6293431
• MDR Text Key: 66333138
• Report Number: MW5067579
• Device Sequence Number: 1
• Product Code: HTX
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE 2MM NLU-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 62