EVA VITRECTOMY TDC KIT 2-STEP 23G
Received Feb 9, 2023 · Event occurred Jan 23, 2023
Report 1222074-2023-00005 · MDR key 16334403
Device
Generic name
Surgical Packs And Kits
Manufacturer
D.o.r.c. Dutch Ophthalmic Research Center Int.Catalog number
8500.23G2T
Lot number
2000439393
Product problems
- Ejection Problem
- Ejection Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IN REGARD TO THIS COMPLAINT, TWO INSERTERS WITH PROTECTION CAPS WERE RECEIVED AT DORC. UNFORTUNATELY, SINCE THE INVOLVED CANNULAS WERE NOT RETURNED, A PHYSICAL EXAMINATION AS TO THE POSSIBLE CAUSE OF THE REPORTED FAILURE COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PREVIOUSLY. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. SINCE THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES AND BECAUSE NO ASSIGNABLE CAUSE OF FAILURE COULD BE DETERMINED, FURTHER ACTIONS ARE DEEMED NOT REQUIRED AT THIS POINT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODE CI-CANN-EJECTED RELATED TO COMPARABLE TROCAR SYSTEMS. PLEASE NOTE: THIS CASE WAS SUBMITTED TO THE FDA BY ERROR. CONCERNED PRODUCT 8500.23G2T IS NOT AVAILABLE ON THE US MARKET.
Description of Event or Problem
WE HAVE BEEN INFORMED THAT WHEN PULLING OUT THE TROCAR INSERTERS, THE TROCAR CAME OUT OF THE EYE ALONGSIDE THE INSERTER. THE SURGEON REPORTED SEEING SOME PARTICLES STUCK TO THE VALVE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.
Additional Manufacturer Narrative
THE COMPLAINT IS UNDER INVESTIGATION.
Description of Event or Problem
WE HAVE BEEN INFORMED THAT WHEN PULLING OUT THE TROCAR INSERTERS, THE TROCAR CAME OUT OF THE EYE ALONGSIDE THE INSERTER. THE SURGEON REPORTED SEEING SOME PARTICLES STUCK TO THE VALVE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.