MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CAMERA HEAD

Model Number	MAJ-554
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the evaluation found that the cable section's head side had a breakage, the cable section had wound penetration, and the cable section had abrasion at the cable section.The investigation is ongoing, and follow-up with the user facility is being performed.A supplemental report will be submitted upon completion of the investigation or if the user facility provides any additional information.
Event or Problem Description
The customer reported to olympus that the camera head image would not appear.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.D4: udi (b)(4).Was added as it was inadvertently left off the initial mdr.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.The device evaluation found that the cable was damaged on the camera head side, the cable was scratched and demonstrated wear.Based on the results of the legal manufacturer¿s investigation, there was no clear image from the camera head due to image noise, due to communication failure caused by a damaged camera head cable.However, the cause of the damaged cable could not be determined.The event can be detected/prevented by handling the device according to the instructions for use that state: ·do not apply excessive force (bend, twist or squeeze), to the camera cable, as the wires may break.Never excessively bend, pull, twist, squeeze or apply a crushing force to the camera cable.Damage will result.Olympus will continue to monitor field performance for this device.

• Brand Name: CAMERA HEAD
• Common Device Name: CAMERA HEAD
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18276257
• Report Number: 3002808148-2023-13830
• Device Sequence Number: 3225881
• Product Code: GCJ
• UDI-Device Identifier: 04953170136931
• UDI-Public: 04953170136931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: MAJ-554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2012
• 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