MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE

Model Number CLH-SC

Device Problem Energy Output Problem (1431)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon could be duplicated.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during an unspecified timing, the device didn't work and the lamp didn't light on even though it was replaced.There was no report of patient injury associated with the event.The event date was unknown.The device is an olympus asset.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record could not be reviewed because the subject device was manufactured more than 15 years ago.It was considered that there was a high possibility that the reported phenomenon occurred due to the influence that the temperature fuse broke.The service life is 6 years.Since the device was manufactured for more than 20 years ago and it was used for a long time, it was considered that there was a high possibility that the temperature fuse broke and the reported phenomenon occurred.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: HALOGEN 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: 12352207
• MDR Text Key: 267627836
• Report Number: 8010047-2021-10583
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLH-SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1