MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO ADAPTER

Model Number	AR-T12E
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is related to patient identifier: (b)(6).Model: otv-s7h-1n, serial (b)(6).The device has not been returned by the customer.The investigation is ongoing.A supplemental report will be submitted when the investigation has been completed or additional information has been received.
Event or Problem Description
It was reported that the subject device displayed a blurred image.The issue was found during preparation for use for a therapeutic laparoscopic surgery.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed.A device history review could not be conducted because lot/serial number information was not available.Based on the results of the investigation, the root or probable cause could not be identified.This issue is addressed in the instructions for use (ifu): chapter 4 operation(warning) ¿ if an abnormal endoscopic image/function occurs and returns to its normal condition by itself, the equipment has malfunctioned.Continued use in such condition may cause abnormality again and it may not be able to recover to normal condition.In this case, immediately stop use and withdraw the endoscope from the patient slowly.Continued use of such equipment may cause patient injury, bleeding and/or perforation.¿ if the endoscopic image on the video monitor should unexpectedly disappear or freeze during an examination and cannot be restored, turn the otv-s7v off and then on again.If the image still does not appear, immediately turn the otv-s7v off.Disconnect the camera head from the endoscope and carefully withdraw the endoscope from the patient, while viewing through the endoscope¿s eyepiece.In addition, be sure to prepare another camera head to ensure that the examination does not need to be interrupted due to equipment failure or malfunction.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that the subject device displayed a blurred image.The issue was found during preparation for use for a therapeutic laparoscopic surgery.There were no reports of patient harm.
Event or Problem Description
It was reported that the subject device displayed a blurred image.The issue was found during preparation for use for a therapeutic laparoscopic surgery.There were no reports of patient harm.
Additional Manufacturer Narrative
E2, e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The device was not returned to olympus for evaluation and the customer's allegation could not be reproduced.Olympus will continue to monitor the field performance of this device.

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18837340
• Report Number: 3002808148-2024-31179
• Device Sequence Number: 7457784
• Product Code: GCJ
• UDI-Device Identifier: 04953170023804
• UDI-Public: 04953170023804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR-T12E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2024
• Supplement Date Received by Manufacturer: Not provided; 06/07/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/05/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTV-S7H-1N CAMERA HEAD
• Patient Sex: Unknown