LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
Received Feb 24, 2021 · Event occurred Feb 10, 2021
Report 9610773-2021-00081 · MDR key 11371886
Device
Generic name
Light Guide And Accessories
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA03300ACatalog number
WA03300A
Lot number
201W0001
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Blister
- Burn(s)
- Blister
Narrative
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF 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 WHEN THE DRAPE WAS REMOVED FROM THE PATIENT AFTER A SUCCESSFULLY COMPLETED THERAPEUTIC TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A BURN INJURY OF APPROX. 22.5-23.5 MM ON ONE LEG. IT IS ASSUMED THAT THE BURN OCCURRED WHEN THE LIGHT-GUIDE CABLE WAS SHORTLY PLACED ON THE PATIENT AFTER IT HAD BEEN REMOVED FROM THE SCOPE. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IN THE CASE AT HAND, THERE WAS NO REPORT OF A MALFUNCTION OF THE AFFECTED DEVICE AND, THEREFORE, IT CAN BE ASSUMED THAT THE LIGHT-GUIDE CABLE WAS IN STANDARD CONDITION AND THE BURN INJURY MOST LIKELY RESULTED FROM THE USER PLACING THE CABLE ON THE PATIENT'S LEG AFTER DISCONNECTING IT FROM THE TELESCOPE. WHEN THE CABLE IS USED IN A PROCEDURE, HEAT BUILDS UP IN THE CABLE. THIS IS CLEARLY STATED AS A WARNING IN THE INSTRUCTIONS FOR USE. HOWEVER, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE LIGHT-GUIDE CABLE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.