FDA Adverse Event Malfunction Summary report: N

RONGUER, IVD CUSHING

MDR report key: 6237744 · Received January 6, 2017

Report

Report Number
MW5067150
Event Type
Malfunction
Date Received
January 6, 2017
Date of Event
January 4, 2017
Report Date
January 6, 2017
Manufacturer
BD/ V. MUELLER
Product Code
HAE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

INFORMATION PROVIDED STATES: PITUITARY RONGEUR BROKE WHILE DISSECTING AND FELL IN WOUND. SURGEON WAS ABLE TO REVIEW THE PIECE OF INSTRUMENTATION. (THIS IS AN FYI, AS APPARENTLY THESE DO BREAK, BUT WE WANTED TO MAKE SURE YOU WERE AWARE IN CASE THERE IS A PROBLEM WITH BREAKAGE.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
13756 RONGUER, IVD CUSHING RONGUER, IVD CUSHING HAE BD/ V. MUELLER VINV03

Patients

Seq Age Sex Outcome Treatment
1 38 YR