SETS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. SPECIFICALLY, WE RECEIVED SIMILAR REPORTS OF SETS LEAKING AT THE DISTAL END OF THE IRRIGATION LINE AND DOWN SCOPES. AT THIS TIME, TWO (2) PRIMARY CAUSES OF THE ISSUE HAVE BEEN DETERMINED: OFF-LABEL USE IN THAT ERBE MEDICAL LLC SETS ARE BEING USED WITH OTHER MANUFACTURERS PORT CONNECTORS (NOTE: PER THE NOTES ON USE FOR THE SET'S, ONLY ERBE ACCESSORIES (I.E., ERBE PORT CONNECTORS), ETC. ARE TO BE USED WITH ERBE TUBING/CAP SETS. A CHANGE HAD BEEN MADE TO THE SET'S CONNECTOR. CURRENTLY SETS ARE NOW BEING PRODUCED WITH THE PREVIOUS CONNECTOR TO MINIMIZE/ELIMINATE LEAKING. OTHER CONTRIBUTING CAUSES OF LEAKING AT THE END OF SCOPES ARE ALSO BEING INVESTIGATED. IF ANY PROMINENT CAUSES ARE DETERMINED AND/OR REMEDIES ARE IMPLEMENTED TO RESOLVE LEAKING, A FOLLOW-UP MDR WILL BE FILED.
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Patient 0
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS? SCOPES & CO2 INTERMITTENTLY OVER THE PAST 4 WEEKS, THERE IS A CONTINUOUS IRRIGATION STREAM. PHYSICIANS HAVE COMPLAINED ABOUT IT DURING PROCEDURES THAT IT DISTORTS THEIR VISUALIZATION. THE STAFF HAVE COMPLAINED THAT IT WILL LEAK FROM DISTAL END OF SCOPE WHILE WAITING FOR PROCEDURE TO START. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) W4468274, DATE OF MANUFACTURING (DOM) 09/11/25, AND EXPIRATION DATE (EXP. DATE) 09/10/28; L/N W4468275, DOM 09/11/25, AND EXP. DATE 09/10/28; L/N WO469444, DOM 09/25/25, AND EXP. DATE 09/24/28; AND L/N WO469448, DOM 09/25/25, AND EXP. DATE 09/24/28] WERE ALSO A PART OF THE COMPLAINT. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.