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

Model Number CLH-SC

Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to omsc for evaluation. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. Omsc checked the subject device and found that the reported phenomenon was not duplicated. In addition, there was no abnormality in visual inspection and operation check. The exact cause of the reported event could not be conclusively determined. However, there was the possibility that this phenomenon was attributed to a temporary contact unstableness due to the exceeded inrush current when the power was turned on. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed from the user that during the preparation for an unspecified procedure at the user facility, it was found that the subject device could not be turned the power on. Therefore, the intended procedure had to be cancelled and postponed. There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10760154
• MDR Text Key: 214147225
• Report Number: 8010047-2020-08312
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/30/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/30/2020
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: CLH-SC
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/23/2020

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown