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

Model Number CLV-190

Device Problems Crack (1135); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, inlet opening was cracked and some of the plastic part was missing on the evis exera iii xenon light source.There was no harm or user injury reported due to the event.During evaluation of the returned device the function control displayed an error message "b30" which means that the scope socket is faulty.This mdr is being submitted based on the reportable malfunction that was found during the evaluation of the device.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered major cosmetic damage, the front panel was broken, the serial number was missing, a faulty scope socket that caused a b30 (scope communication error) and a non-olympus lamp of 500 or more hours.The software version was up to date and the power switch was replaced.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 investigation, device history record review and additional information provided by the customer.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The exact root cause could not be determined.The investigation determined the b30 occurred due to a temporary communication failure.A review of the instrument history showed that the device was purchased on 11/08/2018 and there had been no previous service found.Olympus will continue to monitor the field performance of this device.

Event Description

It is not known when the unit was damaged or how.A delay was not reported as the unit was being used damaged unit and no one was aware of the damage.The device inspected before use as the techs working in the room used the cracked and damaged unit until it was discovered it was damaged.There were no issues and no injury to any patient during that time.The procedure was completed using the same 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: 14597256
• MDR Text Key: 302057993
• Report Number: 8010047-2022-09416
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

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: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/29/2022
• 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