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

Model Number CLV-190

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to any of olympus locations.Therefore, olympus could not investigate the device.The following was confirmed from the information provided by the service department of olympus europa se & co.Kg (oekg): the screws of the xenon lamp for mounting the heat sink were loose and damaged.The user damaged the fastening screws during the last replacement.The user will use xenon lamps from a non-olympus manufacturer to install it on the device.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the routine check prior to the procedure, clv lamp error e103 occurred shortly after the device was turned on.Error code e103 means that the light source has broken down.In addition, the user did not apply enough heat-conducting paste.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The occurrence of the reported clv lamp error e103 may have been caused by the installation and use of a lamp not specified by olympus, either because the user did not notice or ignored the description in the instruction manual.Clv lamp error e103 may have occurred because the lamp failed to light up due to the use of the unspecified lamp.The instruction manual provides a warning to never install a lamp that has not been approved by olympus.By following this instruction, the user may be able to prevent the reported event from occurring.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 12340554
• MDR Text Key: 267274775
• Report Number: 8010047-2021-10455
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1