MAUDE Adverse Event Report: EIZO CORPORATION EIZO; ENDOSCOPIC VIDEO IMAGE DISPLAY MONITOR

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: EIZO
• Common Device Name: ENDOSCOPIC VIDEO IMAGE DISPLAY MONITOR
• Manufacturer (Section D): EIZO CORPORATION; 153; shimokashiwano; hakusan, ishikawa 924-8 566; JA 924-8566
• Manufacturer Contact: hiroaki hashimoto ; 153; shimokashiwano; hakusan, ishikawa 924-8-566 ; JA 924-8566
• MDR Report Key: 17658127
• Report Number: 3000237660-2023-00001
• Device Sequence Number: 6160947
• Product Code: KQM
• UDI-Device Identifier: 04995047053118
• UDI-Public: (01)04995047053118(11)200805
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown