MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Break (1069)

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

Event Date 04/19/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the xenon light source lamp did not light up.The bulb exploded within the scope, causing the glass behind the bulb to break.The issue occurred during an unspecified procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The subject device was returned, and the user¿s report was confirmed.The bulb had exploded, the turret lens was broken, and the scope socket slider was worn out ¿ causing the failure of high intensity mode.Additionally, there was a non-olympus bulb installed on the subject device.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following information related to the reported failure: ¿do not apply excessive force to the light source and/or other instruments connected.Otherwise, damage and/or malfunction can occur.¿ ¿never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction, or a fire.¿ based on the results of the investigation as well as the device evaluation results, it is likely the undue stress on the subject device caused the reported failure mode.However, a definitive root cause could not be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA ELITE 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19196678
• MDR Text Key: 341792893
• Report Number: 3002808148-2024-03938
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2024

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-S190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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