MDR event

Additional Manufacturer Narrative

WE DID NOT RECEIVE ANY OF THE CAMERA EQUIPMENT OR THE SCOPE USED IN THIS PROCEDURE BACK FOR EVAL. HOWEVER, WE DID ADDRESS VARIOUS REPROCESSING ISSUES (CLEANING CHEMICALS, FLASH STERILIZATION, ANTIFOG SOLUTION, MIXING STERILIZATION MODALITIES, ETC.) AT THIS ACCOUNT IN LATE 2006 THAT HAD A NEGATIVE IMPACT ON THEIR SCOPE VISUALS. IT IS POSSIBLE THAT THE SCOPE THEY WERE USING WAS SIMILARLY AFFECTED. AFTER THIS INCIDENT WAS REPORTED, OUR SALES REP BROUGHT IN HIS SAMPLE SCOPES AND PROCEDURES WERE COMPLETED WITH NO GRAINY PICTURE COMPLAINTS.