ENDOINK ENDOSCOPIC MAKER

Additional Manufacturer Narrative

THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. HOWEVER, THE INCIDENT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE INCIDENT INVESTIGATION.

Description of Event or Problem

BY SEARCHING FROM THE FDA MAUDE DATABASE, WE IDENTIFIED ONE ADVERSE EVENT FOR ENDOINK ENDOSCOPIC MAKER. MDR REPORT NUMBER (B)(4). IT WAS REPORTED THAT THE DEVICE PROBLEM IS CONNECTION PROBLEM.

Additional Manufacturer Narrative

1. THE CUSTOMER DID NOT PROVIDE PICTURES OF THE COMPLAINING PRODUCT, AND WE CONDUCTED A SIMULATION EXPERIMENT ACCORDING TO THE DESCRIPTION. WE CONDUCTED EXPERIMENTS WITH THE SAME MODEL OF PRODUCTS, CORRECTLY CONNECTED THE ENDOINK SYRINGE AND THE INJECTION NEEDLE, AND THERE WAS NO SIMILAR DEVICE MALFUNCTION IN THE 5 GROUPS OF THE EXPERIMENT, BUT IF THE SYRINGE AND THE NEEDLE WERE TIGHTENED AND CONTINUED TO ROTATE OR PULL OUTWARD, IT WAS POSSIBLE TO SEPARATE THE LUER JOINT FROM THE SYRINGE. THIS IS CAUSED BY TOO MUCH FORCE WHEN INSTALLING THE NEEDLE. 2. ROOT CAUSE: WE SPECULATED THAT THE DOCTOR USED TOO MUCH FORCE TO REMOVE THE SYRINGE CAP AND THE SYRINGE CAP & THE LUER JOINT WERE REMOVED FROM THE SYRINGE.THIS LEAD TO THE ISSUE HAPPENED. 3. THE CORRECT WAY TO USE WE RECOMMEND: TAKE OUT THE SYRINGE, UNSCREW THE GUARD CAP OF THE SYRINGE, GENTLY ROTATE THE LUER JOINT OF THE INJECTION NEEDLE AND THE LUER JOINT OF THE SYRINGE, AND STOP ROTATING WHEN THE FORCE BECOMES OBVIOUSLY LARGE. 4.IN ORDER TO BETTER ENHANCE THE USER EXPERIENCE. OPTIMIZED SYRINGE LUER, ENDOINK HAS SWITCHED PRE-FILLED SYRINGE. THIS IMROVEMENT CAN PREVENT SUCH PROBLEMS FROM HAPPENING AGAIN. WE WILL CONTINUE TO MONITOR TO MAKE SURE THIS ISSUE IS CLOSED.