WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
Received Sep 16, 2024 · Event occurred Aug 10, 2024
Report 3011137372-2024-00144 · MDR key 20230421
Device
Generic name
Instrument, Ligature Passing A
Manufacturer
Teleflex MedicalModel number
IPN917216Catalog number
EFX002
Lot number
3404480000
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT " WHEN DEVICE WAS PLACED IN THE INTRA-ABDOMINAL AREA WITH THE FIRST DEPLOYMENT, ONE OF THE RETRACTION WINGS BROKE" IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION STATES THAT THERE WERE NO CLINICAL CONSEQUENCES DUE TO THIS INCIDENT AND THE BROKEN PARTS DID NOT FALL INSIDE THE PATIENT.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS NOT RETURNED THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "A REVIEW OF THE INCOMING COMPONENT DHRS (DEVICE HISTORY RECORD) SHOWED NO NCRS RELATED TO THIS ISSUE. NO CONTAINMENT REQUIRED AS THIS ISSUE IS A KNOWN FAILURE MODE. A REVIEW OF THE DHR SHOWED THAT THERE WERE NO ABNORMALITIES OR EXCESSIVE SCRAP NOTED DURING MANUFACTURING. A REVIEW OF THE MEI SHOWS THAT THERE ARE 2 100% INSPECTIONS FOR THIS FAILURE MODE DURING MANUFACTURING. A REVIEW OF THE ISSUE WITH THE OPERATORS SHOWED THAT THERE WERE NO INSTANCES OF INCREASED SCRAP OR ABNORMALITIES DURING MANUFACTURING. A REVIEW OF THE NON-CONFORMING UNITS COULD NOT BE PERFORMED AS THEY WERE NOT AVAILABLE FOR A PHYSICAL REVIEW. THE PICTURES PROVIDED BY THE CUSTOMER DO SHOW THE FAILURE MODE OF A BROKEN WING AND THEREFORE THE COMPLAINT CAN BE VERIFIED. WHILE THE PRESENCE OF THE COMPLAINT CAN BE VERIFIED, THE COMPLAINT IS NOT CONSIDERED VALID AGAINST PARAGON MEDICAL AS THIS FAILURE MODE IS INHERENT TO THE DESIGN (OWNED BY THE CUSTOMER) AND IS 100% INSPECTED AT SEVERAL POINTS DURING MANUFACTURING. NO FMEA OR CAPA UPDATE IS REQUIRED AS THIS FAILURE MODE IS INHERENT TO THE DESIGN. WHILE THIS FAILURE MODE HAS BEEN OBSERVED BEFORE NO FURTHER ACTIONS FROM PARAGON MEDICAL ARE REQUIRED AS THIS FAILURE MODE IS INHERENT TO THE DESIGN." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT " WHEN DEVICE WAS PLACED IN THE INTRA-ABDOMINAL AREA WITH THE FIRST DEPLOYMENT, ONE OF THE RETRACTION WINGS BROKE" IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION STATES THAT THERE WERE NO CLINICAL CONSEQUENCES DUE TO THIS INCIDENT AND THE BROKEN PARTS DID NOT FALL INSIDE THE PATIENT.
Additional Manufacturer Narrative
(B)(4).