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

Model Number	MD-151
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is planned to be returned to olympus but has not been returned to olympus yet.Therefore, olympus could not investigate the subject device.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 or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during the inspection before use, it was found that the subject device (halogen lamp) which was installed into the video system center otv-si did not light up.The user facility switched the subject device to other lamp which was installed inside the otv-si and completed the intended procedure with same otv-si without any problems.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.Olympus medical systems corp.(omsc) could not review the manufacturing history (dhr) of the subject device because the lot number of the subject device was unknown.The exact cause of the reported phenomenon could not be identified.However, based upon the reported information, omsc surmised that this phenomenon was caused by a problem of the subject device (halogen lamp), but could not identify whether the lamp problem was due to the life of the lamp or a defect in the lamp.If additional information is received, this report will be supplemented.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12370314
• Report Number: 8010047-2021-10782
• Device Sequence Number: 3964075
• Product Code: FDS
• UDI-Device Identifier: 04953170064319
• UDI-Public: 04953170064319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: MD-151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female