MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and the following was found: upon inspection and testing of the customer returned device, it was observed that due to excessive stress the output connector or socket is broken, and the scope connector cannot be connected securely.During testing and inspection, the following was also found: the lamp is worn out and needs several attempts to ignite.The water tank holder is worn and deformed.In addition, the control panel is cracked.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility returned the olympus asset, evis exera iii xenon light source, to the olympus service center.Upon inspection and testing of the customer¿s returned device the following was found: damage to the output socket due to excessive stress.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the correction in d9 and the updates in sections h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely the output connector is broken and cannot be connected due to excessive stress to the output socket.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿ once the power of this product and the surrounding equipment to be connected has been turned off reliably, the surrounding equipment should be connected.When the device is connected with the power turned on, the product or surrounding equipment will fail or malfunction.Do not connect other than dedicated cable.When a cable other than a dedicated cable is connected, it may cause not only malfunction but also damage to the device.All wires should be precisely and fully connected.With screws on the connector tighten firmly if it is used.The device is correct if the connection is incomplete doing so may cause not only malfunction but also damage.Do not sharply bend, pull, twist, or crush the cable.Doing so may damage the cable.Do not apply excessive force to the jacket.There is a risk that the connectors will be broken.Use the product under the conditions described in environment and specifications in appendix not only does it work properly when used under other conditions, but it is also safe doing so may damage the unit or cause it to malfunction.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 16499927
• MDR Text Key: 311209840
• Report Number: 3002808148-2023-02200
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• 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