LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT AFTER A CHOLECYSTOTOMY PROCEDURE, A RE-HOSPITALIZATION AND SURGICAL RESUMPTION WAS REQUIRED. IT WAS REPORTED THAT THE PRACTITIONER SUSPECTS A MATERIAL DEFECT. DESPITE SEVERAL EFFORTS TO DATE, NO FURTHER INFORMATION WAS PROVIDED SO FAR.

Additional Manufacturer Narrative

DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE STRAIN RELIEVE OF THE CABLE UNIT IS TORN. A DAMAGED STRAIN RELIEF LED TO THE BREAKAGE OF SOME FIBERS WHICH RESULTED IN REDUCED LIGHT TRANSMISSION. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO USE ERROR. HOWEVER, THE MANUFACTURER CANNOT EVALUATE HOW THIS DAMAGE IS RELATED TO REPORTED RE-HOSPITALIZATION AND SURGICAL RESUMPTION SINCE NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE CABLE UNIT WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT AFTER A CHOLECYSTOTOMY PROCEDURE, A RE-HOSPITALIZATION AND SURGICAL RESUMPTION WAS REQUIRED. IT WAS REPORTED THAT THE PRACTITIONER SUSPECTS A MATERIAL DEFECT. THE PATIENT SUFFERED AN INJURY AND BURN ON THE SMALL INTESTINE/BOWEL WHICH CONSEQUENTLY LED TO SURGICAL RECOVERY AND HOSPITALIZATION IN INTENSIVE CARE UNIT.