THE SET WAS 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.
D
Patient 0
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR OLYMPUS? SCOPES & CO2 LEAKED FROM THE DISTAL END OF THE SCOPE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE SET WAS USED WITH A BOSTON SCIENTIFIC PORT CONNECTOR. DURING THE PROCEDURE, THE PATIENTS O2 LEVEL DROPPED; THEREFORE, THEY WERE INTUBATED. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE O2 LEVEL TO DROP. NEVERTHELESS, AT SOME POINT, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.