MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Leak/Splash (1354); Component or Accessory Incompatibility (2897)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Upon evaluation of the device, the reported event by the customer was confirmed.The valve was not properly connected to the pump and loud noises occurred during use.The hose attached to the base of the light source was dirty from the inside.In addition, the base was slightly corroded in some places and the light tube was broken.The valve, base, and dirty hose required replacement.Furthermore, endoscopic image was too dark due to use of a non-designated lamps and water leaks from the output connector socket due to liquid intrusion into the tube were overserved.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 reported that the evis exera iii xenon light source socket suction hose was contaminated.In addition, intermittent loud running noises when operating the air pump ensued.The event occurred during a colonoscopy procedure and the same device was used to complete the procedure.During a standard service inspection of the customer returned device, liquid intrusion into the tube and use of non-designated lamps were noted.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 26-dec-2021.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, regarding liquid intrusion inside the tube, it is likely that a foreign material or liquid entered inside the hose because the internal hose was detached, so the check valves did not work properly.Regarding the endoscope image is not visible as it is too dark, it is likely that operation became unstable and an image became dark because a non-olympus lamp was used.It is also possible that an image became dark because the lamp itself was faulty.Regarding the light tube is damaged, the hose was detached, therefore, it is likely that the hose was damaged due to vibration of the pump after it was detached, or the hose itself was damaged.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.".

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13471839
• MDR Text Key: 296239864
• Report Number: 8010047-2022-02481
• 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: CLASS2-EXMPT
• 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: 06/17/2022

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: 01/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2012
• 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