THE SETS WERE NOT AVAILABLE FOR AN EVALUATION. NEVERTHELESS, WE HAVE 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 A HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS? SCOPES LEAKED FROM THE TUBING AT THE DISTAL DURING STANDARD ENDOSCOPY. ADDITIONALLY, IT WAS STATED THAT IF THE SETS ARE USED WITH ERBE'S PORT CONNECTOR THEN THE SETS DON'T LEAK.