Description of Event or Problem · 0
ON 30-JAN 2023, EIZO CORPORATION RECEIVED AN INCIDENT REPORT FROM KARL STORZ SE & CO. KG, A LAPAROSCOPY SYSTEM MANUFACTURER. THE INCIDENT INVOLVED A DEVICE (ART. NO.: TM220- 27" FULL HD-MONITOR; SERIAL NO.: (B)(6) MANUFACTURED BY EIZO. BELOW DESCRIPTION OF THE EVENT WERE BASED ON THE INFORMATION PROVIDED BY KARL STORZ SE & CO. KG. THE INCIDENT WITH A LAPAROSCOPY TOWER OCCURRED IN AN INSTITUTION IN COLUMBIA. THE ASSISTING STAFF INDICATES THAT DURING THE SURGICAL PROCEDURE, THE LAPAROSCOPY TOWER WAS TURNED OFF AND WHEN IT WAS TURNED ON, THE IMAGE WAS SHOWN AS A MIRROR IMAGE, CAUSING INJURY TO THE PATIENT. THE PATIENT HAD TO SPEND 15 DAYS IN INTENSIVE CARE. THIS CASE IS ASSOCIATED WITH THE MISUSE OF EQUIPMENT BY THE ASSISTING STAFF, HOWEVER IT COULD NOT BE CLEARLY IDENTIFIED THAT THE MIRROR IMAGE WAS CAUSED BY MISUSE OF THE MONITOR OR MISUSE OF THE ENDOSCOPE SYSTEM. IT WAS ALSO REPORTED THAT KARL STORZ HAD REQUESTED RETURN FOR THE AFFECTED DEVICE FOR FURTHER INVESTIGATION, HOWEVER, THAT THE DEVICE IN QUESTION WON?LT BE RETURNED AS THE KARL STORZ DISTRIBUTOR IN COLUMBIA CONFIRMED MISUSE BY THE CUSTOMER AND THE USED DEVICES ARE IN GOOD CONDITION.