MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LAMP

Model Number	MH-968
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.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 or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use of the clh-250 which the subject device was installed, the subject device was burned out.The damaged subject device was discarded.There was no report of patient injury associated with this event.
Additional 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 exact cause of the reported phenomenon could not be conclusively determined.However, there is a possibility that the reported event occurred due to any of the following causes.There was a change in the supply voltage and overcurrent occurred.The repeated use of the switch of the subject device lead to deterioration.There was a malfunction with the lamp itself.The storage and the operating environment of the lamp and/or the subject device deteriorated the lamp.

• Brand Name: HALOGEN LAMP
• Common Device Name: HALOGEN LAMP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10544416
• Report Number: 8010047-2020-06598
• Device Sequence Number: 19591314
• Product Code: FDS
• UDI-Device Identifier: 04953170028083
• UDI-Public: 04953170028083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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
• Operator of Device: No Information
• Device Model Number: MH-968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1