VORTEX SURGICAL INC

Description of Event or Problem

VORTEX SURGICAL RECEIVED A COMPLAINT FROM OUR KOREAN DISTRIBUTOR ABOUT THE SEAL IN ONE OF OUR STERILE PRODUCT POUCHES. VORTEX INITIATED COMPLAINT 1204 AND REQUESTED RETURN OF THE PRODUCT FOR EXAMINATION. THE RETURNED PRODUCT INCLUDED FOUR INSTANCES OF A SMALL VOID IN THE SEAL FROM THREE DIFFERENT LOTS OF PRODUCT. ROOT CAUSE ANALYSIS DETERMINED THAT THE SEAL FAILURE OBSERVED IN THE FOUR UNITS WAS CAUSED BY AN OPERATOR THAT FAILED TO FOLLOW THE TRAINED SEALING PROCESS. REVIEW OF OUR RECORDS SHOW THAT THE COMPLAINT PRODUCTS WERE PACKAGED AND STERILIZED ON STERILE LOAD 1140 AND 1141 AND WERE RELEASED IN NOVEMBER AND DECEMBER OF 2024. RECALL HAS BEEN ISSUED FOR ALL ITEMS MANUFACTURED ON STERILE LOADS 1140 AND 1141.

Additional Manufacturer Narrative

VORTEX SURGICAL RECEIVED A COMPLAINT FROM OUR KOREAN DISTRIBUTOR ABOUT THE SEAL IN ONE OF OUR STERILE PRODUCT POUCHES. VORTEX INITIATED COMPLAINT 1204 AND REQUESTED RETURN OF THE PRODUCT FOR EXAMINATION. THE RETURNED PRODUCT INCLUDED FOUR INSTANCES OF A SMALL VOID IN THE SEAL FROM THREE DIFFERENT LOTS OF PRODUCT. ROOT CAUSE ANALYSIS DETERMINED THAT THE SEAL FAILURE OBSERVED IN THE FOUR UNITS WAS CAUSED BY AN OPERATOR THAT FAILED TO FOLLOW THE TRAINED SEALING PROCESS. REVIEW OF OUR RECORDS SHOW THAT THE COMPLAINT PRODUCTS WERE PACKAGED AND STERILIZED ON STERILE LOAD 1140 AND 1141 AND WERE RELEASED IN NOVEMBER AND DECEMBER OF 2024. AS A CONTAINMENT ACTION, WE HAVE INSPECTED THE POUCH SEALS OF OUR INVENTORY AND DID NOT FIND THE SAME FAILURE METHOD IN ANY OF THE (B)(4) POUCHES THAT WERE INSPECTED.