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

Model Number MD-151

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report has been returned to omsc, but is not started to evaluate.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by one of the health professionals at the user facility that during the preparation of a otorhinolaryngology endoscopy using the subject device and otv-si, the lamp did not light up.The intended procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation and investigation.The manufacture date was unknown because the serial was unknown.The indicated phenomenon was reproduced.It was confirmed from the combination survey that the lamp did not light up.When the appearance was confirmed, it was confirmed that the filament had come off.It is highly probable that the filament (tungsten) deteriorated due to the storage environment of the lamp, and the indicated phenomenon occurred.The above device handling has warned in the instruction manual.

• Brand Name: HALOGEN LAMP
• Type of Device: 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: 12298710
• MDR Text Key: 265892416
• Report Number: 8010047-2021-09994
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170064319
• UDI-Public: 04953170064319
• Combination Product (y/n): N
• PMA/PMN Number: K002231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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
• Device Operator: Health Professional
• Device Model Number: MD-151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1