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

Model Number	AR-T12E
Medical Device Problem Codes	Corroded (1131); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the camera head leads had poor contact, the cable of camera head is twisted and distorted, resulting in horizontal stripes in the image, camera head and adapter are corroded and cannot be disassembled.No additional information provided.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion or if additional information is received.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide the final investigation results and additional information.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Poor cable contact (indicated by the user was reproduced by the repair department.The cause has already been isolated as the occurrence of horizontal stripes in the image due to a twisted cable in the combination device.In addition, a new appearance abnormality was observed.The head and adapter are corroded and cannot be disassembled.A definitive root cause cannot be identified.A device history review cannot be performed due to lack of lot/serial no.Information.The instruction manual for the device in question was checked.As a result, no abnormality was found.-are the reported risk or harms documented in the ifu? ¿warning/caution is stated.(refer to the relevant section of the ifu) -was the device used according to the ifu and the label? it could not be determined from the complaint information whether it was used in accordance with the ifu.-does the ifu/label need to be revised or is there a problem with the translations, descriptions, or figures? ¿no need to be revised.Section where ifu applicable] 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 off and then on again.If the image still does not appear, immediately turn 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.
Additional Manufacturer Narrative
This report is being submitted for correction to the device model number.Please see updates to the following fields: d4 (model number, udi), h2, h4 and h10.This report captures the complaint on video adapter.The related camera head complaint is captured in patient identifier: (b)(6) (report ref #: 3002808148-2023-20019-00).

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18460969
• Report Number: 3002808148-2024-30056
• Device Sequence Number: 15251977
• Product Code: GCJ
• UDI-Device Identifier: 04953170023804
• UDI-Public: 04953170023804
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 02/01/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/30/2024; 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Patient Sex: Unknown