LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE
Received Jul 13, 2020 · Event occurred Jul 8, 2020
Report 9610773-2020-00155 · MDR key 10263313
Device
Generic name
Light Guide And Accessories
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA03310ACatalog number
WA03310A
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn, Thermal
- Burn, Thermal
Narrative
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, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LIGHT-GUIDE CABLE FOR THE LAST 24 MONTHS OF PRODUCTION WITHOUT SHOWING ANY ABNORMALITIES. FURTHERMORE, AS CLEARLY STATED AS A CAUTION NOTE IN THE INSTRUCTIONS, THE TELESCOPE'S DISTAL END OR THE LIGHT-GUIDE CONNECTOR MUST NOT BE PLACED ON THE PATIENT'S SKIN, ON FLAMMABLE MATERIALS OR ON HEAT-SENSITIVE MATERIALS AS OTHERWISE THERE IS A RISK OF THERMAL INJURY TO THE PATIENT'S TISSUE, BURNS TO THE PATIENT'S OR USER'S SKIN OR BURNS OR THERMAL DAMAGE TO SURGICAL EQUIPMENT. THE USER APPARENTLY DID NOT FOLLOW THESE INSTRUCTIONS AS THE PATIENT REPORTEDLY SUSTAINED A SECOND DEGREE BURN DURING USE. THUS, THIS INCIDENT WAS ATTRIBUTED TO USE-ERROR. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.
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 DURING AN UNSPECIFIED THERAPEUTIC PEDIATRIC SURGERY, THE PATIENT SUSTAINED A SECOND DEGREE BURN WHEN THE LIGHT-GUIDE CABLE AND THE CONNECTING PART OF THE RIGID ENDOSCOPE CAME INTO CONTACT WITH THE PATIENT¿S SKIN. THE AFFECTED AREA WAS 2 CM X 5 MM IN SIZE. IT WAS REPORTED THAT THE BURN DID NOT REQUIRE ANY MEDICAL OR SURGICAL TREATMENT. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME OF EQUIPMENT.