LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
Received Dec 21, 2022 · Event occurred Oct 24, 2022
Report 9610773-2022-00708 · MDR key 16022547
Device
Generic name
Lightsource
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA03300ACatalog number
WA03300A
Lot number
21XW0007
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Male
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
OLYMPUS WAS INFORMED THAT ONE DAY AFTER A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE A BURN OF APPROX 1.04 INCHES WAS DISCOVERED ON THE PATIEN'S THIGH. A SKIN GRAFT WAS PERFORMED AT THE LOCATION OF THE BURN INJURY AND THE PATIENT WAS DISCHARGED FROM HOSPITAL.
Additional Manufacturer Narrative
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, SINCE THERE WAS NO REPORT OF ANY DEFECT OR MALFUNCTION OF THE INVOLVED LIGHT-GUIDE CABLE, IT IS ASSUMED THAT THE ARTICLE IS VERY LIKELY IN STANDARD CONDITION. 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 LIGH-GUIDE CABLE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON 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.