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

Model Number	MAJ-554
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the camera head displayed a noisy and flickering image.The issue was found during preparation for use for an ear, nose, and throat endoscopy procedure.The intended procedure was completed a different video system center and scope with no surgical delay.The concomitant devices were working as intended.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the camera head displayed a noisy and flickering image.The issue was found during preparation for use for an ear, nose, and throat endoscopy procedure.The intended procedure was completed a different video system center and scope with no surgical delay.The concomitant devices were working as intended.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device evaluation and on legal manufacturer's final investigation.Updated: d8, h2, h3, h4, h6, h10 the device was returned for olympus for evaluation and the user¿s request was confirmed.Based on the results of the results of the investigation, it is presumed that the video function did not function properly due to the cable disconnection and poor contact, and that "noise and flickering in the image" occurred.However, a definitive root cause could not be identified.The storage period of device history record (dhr) is 15 years.Dhr could not be verified since the device was manufactured more than 15 years ago.This issue is addressed in the instructions for use (ifu): ¿ incorrect cable connection may result in inadequate image display or no image on the video monitor olympus will continue to monitor the performance of 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18751208
• Report Number: 3002808148-2024-30879
• Device Sequence Number: 3837495
• Product Code: GCJ
• UDI-Device Identifier: 04953170136931
• UDI-Public: 04953170136931
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2007
• 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: LMD-2110MD.; OTV-SC.; STORZ LIGHT SOURCE.; THIRD PARTY TELESCOPE.
• Patient Sex: Unknown