ELMED INCORPORATED

Additional Manufacturer Narrative

ORIGINAL MFR REPORT NUMBER 1412854-2024-12241. UF/IMPORTER REPORT: (B)(4). UPON NOTIFICATION, WE PULLED ALL INVENTORY (ITEM ST315503) FROM STOCK AND CHECKED THEM; NO ISSUES FOUND ON THE 9 UNITS IN STOCK. REACHED OUT TO THE RISK MANAGER NOTED ON THE NOTIFICATION IN ORDER TO GET THE DEVICE BACK FOR EVALUATION. RISK MANAGER CONFIRMED THEY HAD THE PRODUCT AND WOULD PROVIDE STANDARD RELEASE TO US SO THAT SHE COULD SEND IT BACK TO US. HAD RISK MANAGER RECONFIRM THE SN AND MARKINGS (ST315502 AND E0824) BASED ON THE DATE CODE, THE PRODUCT WAS FROM AUGUST OF 2024 PRODUCT NUMBER WAS DIFFERENT THAN WHAT WAS INDICATED ON THE MEDICAL DEVICE REPORT; AS A RESULT, WE PULLED ALL INVENTORY ON ITEM ST315502 AND DID AN EVALUATION ON THOSE ITEMS - NO ISSUES FOUND ON THE 13 UNITS IN STOCK. RISK MANAGER CONFIRMED THAT IT WAS THE 1.3 CM DEVICE IN QUESTION. QUESTION POSED TO RISK MANAGER WAS WHETHER THE LOCATION HAS ADDITIONAL 1.3 CM DEVICES IN USE/AT THE SITE. WE ASKED IF THERE WAS A CHANCE THAT WHEN THE PRODUCT IS CLEANED AND PROCESSED THAT THE INDIVIDUAL PARTS CAN GET INADVERTENTLY INTERCHANGED. RISK MANAGER CONFIRMED THAT UPON COMPLETION OF THE PRODCEDURE, THE PARTS ARE DISASSEMBLED COMPLETELY AND PLACED IN THE CONTAINER FOR STERILIZATION TO PROCESS. SHE STATED THAT AS A RESULT, ONE BIN MAY END UP WITH SEVERAL DIFFERENT SETS WHICH COULD END UP WITH THE PARTS BEING INADVERTENTLY INTERCHANGED. WE REQUESTED (Q. 5) 1.3 CM PRODUCTS THAT THE LOCATION HAD ON SITE AND WE WOULD PROVIDE 5 IN EXCHANGE SO THAT WE COULD CONTINUE OUR INVESTIGATION BUT WE DID NOT HEAR BACK. BASED ON CORRESPONDENCE, WE CAN ONLY CONCLUDE THAT THE PARTS WERE INTERCHANGED AS THE RISK MANAGER CONFIRMED THAT THIS COULD IN FACT HAPPEN AT THEIR END. WE WILL REVIEW HOW AND IF TO INCORPORATE A STATEMENT WITHIN THE IFU REGARDING THE NECESSITY TO KEEP THE COMPONENTS OF THE FINAL ASSEMBLY TOGETHER AND NOT INTERCHANGE THEM DUE TO THE POSSIBILITY OF SLIGHT TOLERANCE DIFFERENCES WHICH COULD RESULT IN THE DEVICE NOT FUNCTIONING AS INTENDED.

Description of Event or Problem

ITEM: ST315502. GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2"). PER THE CUSTOMER, WHEN THE BELL WAS SEATED, IT WAS LOOSE. THIS CREATED AN INCOMPLETE HEMOSTASIS, RESULTING IN BLEEDING AFTER CIRCUMCISION. NO ADDTIONAL INJURY WAS REPORTED BY THE CUSTOMER. NOTE: THIS IS A FOLLOW-UP TO THE REPORT (B)(4) PREVIOUSLY SUBMITTED UPON INITIAL RECEIPT AND IS A SUPPLELMENT REPORT (TO REPORT 1412854-2025-20251) WHICH WAS REQUESTED BY THE MDR DATA SYSTEMS TEAM TO INCLUDE THE UF/IMPORTER REPORT NUMBER (B)(4) IN THE BLOCK H10 FIELD.

Additional Manufacturer Narrative

ORIGINAL MFR REPORT NUMBER: 1412854-2024-12241 UF/IMPORTER REPORT: (B)(4). UPON NOTIFICATION, WE PULLED ALL INVENTORY (ITEM ST315503) FROM STOCK AND CHECKED THEM; NO ISSUES FOUND ON THE 9 UNITS IN STOCK REACHED OUT TO THE RISK MANAGER NOTED ON THE NOTIFICATION IN ORDER TO GET THE DEVICE BACK FOR EVALUATION RISK MANAGER CONFIRMED THEY HAD THE PRODUCT AND WOULD PROVIDE STANDARD RELEASE TO US SO THAT SHE COULD SEND IT TO US HAD RISK MANAGER RECONFIRM THE SN AND MARKINGS (ST315502 AND (B)(6). BASED ON THE DATE CODE, THE PRODUCT WAS FROM AUGUST OF 2024 PRODUCT NUMBER WAS DIFFERENT THAN WHAT WAS INDICATED ON THE MEDICAL DEVICE REPORT; AS A RESULT WE PULLED ALL INVENTORY ON ITEM ST315502 AND DID AN EVALUATION ON THOSE ITEMS - NO ISSUES FOUND ON THE 13 UNITS IN STOCK RISK MANAGER CONFIRMED THAT IT WAS 1.3CM DEVICE IN QUESTION POSED TO RISK MANAGER WAS WHETHER THE LOCATION HAS ADDITIONAL 1.3CM DEVICES IN USE/AT THE SITE. WE ASKED IF THERE WAS A CHANCE THAT WHEN THE PRODUCT IS CLEANED AND PROCESSED THAT THE INDIVIDUAL PARTS CAN GET INADVERTENTLY INTERCHANGED. RISK MANAGER CONFIRMED THAT UPON COMPLETION OF THE PROCEDURE, THE PARTS ARE DISASSEMBLED COMPLETELY AND PLACED IN THE CONTAINER FOR STERILIZATION TO PROCESS. SHE STATED THAT AS A RESULT, ONE BIN MAY END UP WITH SEVERAL DIFFERENT SETS WHICH COULD END UP WITH PARTS BEING INADVERTENTLY INTERCHANGED. WE REQUESTED (Q.5) 1.3CM PRODUCTS THAT THE LOCATION HAD ON SITE AND WE WOULD PROVIDE 5 IN EXCHANGE SO THAT WE COULD CONTINUE OUR INVESTIGATION BUT WE DID NOT HEAR BACK. BASED ON CORRESPONDENCE, WE CAN ONLY CONCLUDE THAT THE PARTS WERE INTERCHANGED AS THE RISK MANAGER CONFIRMED THAT THIS COULD IN FACT HAPPEN AT THEIR END. WE WILL REVIEW HOW AND IF TO INCORPORATE A STATEMENT WITHIN THE IFU REGARDING THE NECESSITY TO KEEP THE COMPONENTS OF THE FINAL ASSEMBLY TOGETHER AND NOT INTERCHANGE THEM DUE TO THE POSSIBILITY OF SLIGHT TOLERANCE DIFFERENCES WHICH COULD RESULT IN THE DEVICE NOT FUNCTIONING AS INTENDED.

Description of Event or Problem

ITEM: ST315502 GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2"). PER THE CUSTOMER, WHEN THE BELL WAS SEATED, IT WAS LOOSE. THIS CREATED AN INCOMPLETE HEMOSTASIS, RESULTING IN BLEEDING AFTER CIRCUMCISION. NO ADDITIONAL INJURY WAS REPORTED BY THE CUSTOMER. NOTE: THIS IS A FOLLOW-UP TO THE REPORT (2024-12241) PREVIOUSLY SUBMITTED UPON INITIAL RECEIPT.