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 Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus repair center in hamburg for evaluation. Olympus repair center inspected the device and confirmed the following; the reported phenomenon was reproduced. The front panel was broken. There were small holes in the hose of the air supply line. The halogen lamp had low power and was dark. The air pump was difficult to operate under pressure. The bottom plate, screws, and rear panel were corroded by moisture. The reported event that the power switch failed appeared to be caused by aging deterioration because more than 12 years have passed since the device was manufactured. Olympus concluded that the device did not work because the device did not turn on due to a power switch failure. Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed by the user that the power switch failed and the device did not work. There was no report of patient injury associated with the 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: 11129040
• MDR Text Key: 225598743
• Report Number: 8010047-2021-00985
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CLK-4
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown