FDA Adverse Event Malfunction Summary report: N

GLIDESCOPE GVL 3

MDR report key: 2972144 · Received February 15, 2013

Report

Report Number
9615393-2013-00075
Event Type
Malfunction
Date Received
February 15, 2013
Date of Event
January 17, 2013
Report Date
January 17, 2013
Manufacturer
VERATHON MEDICAL (CANADA) ULC.
Product Code
CCW
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
VA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED ISSUE WAS CONFIRMED BY VISUAL INSPECTION. THE CASING WAS CRACKED ON THE HANDLE. THE DEVICE WAS REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A CRACK IN THE BLADE. NO PT INJURY WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
69492 GLIDESCOPE GVL 3 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0007

Patients

Seq Age Sex Outcome Treatment
1