HF-RESECTION ELECTRODE PLASMALOOP ¿ MEDIUM, 30 DEG, 24 FR
Received Jan 8, 2019
Report 2951238-2019-00340 · MDR key 8229981
Device
Generic name
Electrode, Electrosurgical
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA47506SCatalog number
WA47506S
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. TO MITIGATE AGAINST GENERAL DEVICE BREAKAGE, THE DEVICE INSTRUCTIONS FOR USE WARNS AGAINST BENDING THE DISTAL TIP. THE INSTRUCTIONS FOR USE ALSO HAVE PRE-PROCEDURE DIRECTIONS FOR INSPECTING BOTH THE DEVICE AND ITS PACKAGING FOR DAMAGE AND DEFORMATION. THE INSTRUCTIONS FOR USE ALSO RECOMMENDS THAT THE STORED DEVICE NOT BE EXPOSED TO SUNLIGHT OR HAVE ITS PACKAGING CRUSHED BY SURROUNDING OBJECTS.
Description of Event or Problem
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE DEVICE DETACHED INSIDE THE PATIENT. THE DETACHED TIP WAS RETRIEVED USING AN UNKNOWN MEANS. THERE WAS NO REPORTED PATIENT INJURY.