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

Model Number MAJ-554

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

It was reported, that the cable head on the video system center was damaged, causing interference when moving it.The issue occurred following the procedure.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported event was confirmed.The evaluation found the image with interference is detected showing vertical stripes, when moving the cable.The likely cause of the reported event is due to cable internal failure.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide a correction to b5, d1, d2, d4 model number and udi.Olympus will continue to monitor field performance for this device.

Event Description

It was reported the cable head was damaged, causing interference when moving it.The issue occurred following the procedure.There were no reports of patient harm.

• Brand Name: CAMERA HEAD
• Type of Device: 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: 18596864
• MDR Text Key: 334842414
• Report Number: 3002808148-2024-00846
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170136931
• UDI-Public: 04953170136931
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 04/01/2024; 04/26/2024
• Supplement Dates FDA Received: 04/01/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1