STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿)

Description of Event or Problem

THE USER FACILITY REPORTED DURING A RETINA CASE THE PRODUCT WAS LEAVING DIAMOND DUST BEHIND. THEY DISCONTINUED USING THE MEMBRANE SCRAPPER. ANOTHER MEMBRANE SCRAPPER WAS OPENED ON THE FIELD AND USED WITHOUT ANY ISSUES. THE DOCTOR LATER REPORTED THE DIAMOND DUST WAS REMOVED WITH VITRECTOR AND SOFT TIP EXTRUSION CANNULA.

Additional Manufacturer Narrative

THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE COMPLAINT CONDITION COULD NOT BE REPLICATED AS THE SILICONE TIP TO WHICH THE DIAMOND DUST IS BONDED WAS NOT PRESENT ON THE RETURNED PRODUCT OR IN THE PACKAGING. THE PORTION OF SILICONE BEAD STILL PRESENT AND VISIBLE INSIDE THE SHAFT HAS A ROUGH IRREGULAR SURFACE CONSISTENT WITH HAVING BEEN TORN. INSTRUCTIONS FOR USE STATE: ONLY RETRACTABLE DDMS PRODUCTS (20.16, 20.16.23, 20.16.25) ARE COMPATIBLE WITH VALVED CANNULA SYSTEMS. USE OF OTHER DDMS PRODUCTS (20.04, 20.04.23, 20.04.25S, 20.04.27, 20.07, 20.18) WITH VALVED CANNULA SYSTEMS MAY DAMAGE FLEXIBLE TIP. THE HOSPITAL CONFIRMED THAT THIS DEVICE WAS BEING USED WITH AN VALVED CANNULA. THIS IS A CONTRAINDICATED ACTION. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.