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

Model Number CLK-4

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(4) group, for evaluation.Ocg inspected the device and confirmed the following; the power switch connector was broken.The device did not start up due to the power switch connector failure.There were mechanical damages to the device.There was an abnormal noise due to a malfunction of the air pump.The device cover was damaged.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 Description

Olympus medical systems corp.(omsc) was informed by the user that the device did not start up.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.According to additional information provided by the user facility, the reported event occurred during preparation for use.Therefore, the user facility did not use the device for the intended procedure.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp.(omsc).However, the reported event may have been caused by a damaged power switch connector due to long-term repeated use, because more than 22 years have passed since the device was delivered.In addition, the breakage of the device cover may have been caused by a strong impact from the user hitting the device against a hard object.And the air pump may have failed due to wear from repeated use over a long period of time.The instruction manual provides preventive measures against against damage to the device cover.Omsc could not be confirmed the device history record, because the device was manufactured over 15 years ago.If additional information becomes available, this report will be supplemented.

• 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: 11283739
• MDR Text Key: 243686146
• Report Number: 8010047-2021-02251
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024528
• UDI-Public: 04953170024528
• Combination Product (y/n): N
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

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: No Information
• Device Model Number: CLK-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1