MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problems Communication or Transmission Problem (2896); Device Markings/Labelling Problem (2911); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the reportable finding documented in b5, the non-reportable evaluation findings are as follows: front panel was cracked, top cover was deformed, chassis was deformed, rear panel was deformed, an unusual sound was heard when the turret rotated due to damage on the filter turret, and the control panel was cracked.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the xenon light source had housing damage.The device was returned for evaluation.During the device evaluation it was found that: the endoscope could not be identified because the scope socket was worn out, the direction of airflow from the fan was not correct due to damage on the fan, and the direction of airflow from the fan was not correct due to damage on the power supply unit.There were no reports of patient harm or injury.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: h6 problem code ("2911 - device markings / labelling problem" should be removed and replaced with 2896).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.It is likely the reported, scope cannot be identified, occurred due to a worn scope socket.It is likely the, incorrect airflow direction from the fan, occurred due to a broken fan and power supply unit failure.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• 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: 18388576
• MDR Text Key: 331400996
• Report Number: 3002808148-2023-14691
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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