MalfunctionCCX

YELLOFINS

Received Oct 18, 2019 · Event occurred Dec 21, 2018

Report 9207799 · MDR key 9207799

Device

Generic name

Support, Patient Position

Manufacturer

Allen Medical Systems, Inc.

Catalog number

O-YFASI

Product problems

Unintended Movement

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

YELLOWFIN STIRRUP- THIS IS A POSITIONING DEVICE. THE DEVICE DRIFTED INWARD DURING CASE- IT HAS BEEN SENT OUT FOR REPAIR. IT WAS USED FOR 2 PROCEDURES AND IT HAPPENED BOTH TIMES.