ROTATING CONTINUOUS FLOW INNER SHEATH
Received Aug 12, 2014 · Event occurred Jul 23, 2014
Report 2951238-2014-00332 · MDR key 4071882
Device
Generic name
Inner Sheath
Manufacturer
Gyrus Acmi Inc.Model number
GERIS-CF25Catalog number
GERIS-CF25
Lot number
UNK
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE PLASTIC PIECE ON THE TIP OF THE INNER SHEATH BROKE OFF AND FELL INSIDE THE PATIENT. THE PLASTIC PIECE WAS RETRIEVED FROM THE PT. THERE WAS NO INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE IN AN EFFORT TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT WITH NO RESULTS.
Additional Manufacturer Narrative
THE DEVICE REFERENCE I THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.