MAUDE Adverse Event Report: BD V. MUELLER SNOWDEN PENCER COTTLE; SEPTUM ELEVATOR

Model Number MOELLER A-3

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2016

Event Type  Injury  

Event Description

Cottle elevator used in ent surgery broke during sinus surgery.The surgeon retrieved the broken piece with no harm to the patient.

• Brand Name: SNOWDEN PENCER COTTLE
• Type of Device: SEPTUM ELEVATOR
• Manufacturer (Section D): BD V. MUELLER; franklin lakes NJ 07417
• MDR Report Key: 6225085
• MDR Text Key: 64025753
• Report Number: MW5067056
• Device Sequence Number: 1
• Product Code: KAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MOELLER A-3
• Device Catalogue Number: 88-3873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention