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

Model Number	AR-T10E
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2: no.Additional issues found during the evaluation were breakage of the detachable knob, damage to the scope clamp and corrosion of the lens on the connection side of the camera head.A definitive root cause cannot be identified.Dhr review cannot be performed due to lack of lot or serial no.Information.This issue is addressed in the instructions for use (ifu): the instruction manual for the subject device (gc4549 (edition: 17)) was checked.As a result, no abnormality was found.-are the reported risks/harms documented in the ifu? an alert/warning is provided regarding phenomenon 1.(refer to ifu where applicable) -was the ifu/label used according to the label? the complaint information did not identify 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 revise.[section where ifu applicable for phenomenon 1].6.2 attaching to and removing from the scope (ar-t10e, t12e) (causion).When loosening the scope lock, be careful not to turn it too hard in the loosening direction.It may damage the scope lock.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed that during the device evaluation, the adaptor exhibited corrosion of the r-lock unit and e-coupler unit.There were no reports of patient involvement.

• 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: 18820841
• Report Number: 3002808148-2024-31143
• Device Sequence Number: 4387636
• Product Code: GCJ
• UDI-Device Identifier: 04953170023729
• UDI-Public: 04953170023729
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: Other
• Device Model Number: AR-T10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/1950
• 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
• Patient Sex: Unknown