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

Model Number CLV-190

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

The customer reported the evis exera iii xenon light source inlet connector is broken, and metal part is exposed.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device has been received however; the estimation has not been completed as of date.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to b5, d8, h3 and the device evaluation.Please see updates to b5, d8, h3, h4, h6 and h10.B5 d8, h3: the information in these fields, as well as the device evaluation in h10 were inadvertently omitted from the initial medwatch report.In additional to the malfunction reported in b5, the device was returned to olympus for inspection, and the customer's complaint was confirmed.Additionally, the repair center found there was cosmetic damage to the front panel, a faulty scope socket, a broken power switch, and there was a non-olympus lamp installed.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, it¿s likely the front panel blinked due to the damaged inlet, broken locking mechanism and broken slide switch.However, a final root cause of the reported event and damage was unable to be identified.Olympus will continue to monitor field performance for this device.

Event Description

Upon inspection and testing of the customer returned device, it was observed that the locking mechanism and scope detection slide were not functioning as intended.This caused the front panel to blink constantly.This report is being submitted for the malfunction found during the device evaluation, as well as the broken inlet connector.

• 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: 16084111
• MDR Text Key: 308106714
• Report Number: 3002808148-2023-00006
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/02/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2018
• 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