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

Model Number CLK-4

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2020

Event Type  Malfunction  

Manufacturer Narrative

The returned asset device was sent to the service center for evaluation. The evaluation found the air pressure was low due to faulty air pump unit & worn out air joint unit & connector socket. In addition, found two of the halogen lamps were missing inside. The top cover, bottom chassis was deformed & the front panel was damaged. The four feet at the bottom of he unit were worn out. The asset device was repaired and returned to inventory. A review of the repair records show the asset was last serviced on (b)(6) 2017 and met standard specification. No repairs were performed as the device was returned to asset inventory. The original equipment manufacturer (omsc) could not perform a device history record review because the production date is unknown. The omsc shipped the device on (b)(6) 2002. Based on the investigation results, the potential causes of the reported lamp failure may be attributed to the following: the lamp may have blown, but more than 17 years have passed since it was delivered, and it is assumed that the thermal fuse failed because lamp replacement is considered user-friendly. It is considered probable that the thermal fuse was blown due to an accidental failure of the thermal fuse or overheating in the device, because the thermal fuse was not restored. The temperature fuse might have blown out because the user had put other equipment on the air intake and exhaust ports, etc. , and it was used in an environment in which the conditions of intake and exhaust were bad. As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: the light source ventilation grill and openings should be clear of ancillary equipment. Blockage can cause overheating and equipment damage.

Event Description

The sales representative reported an out of the box failure; during inspection the halogen light source lights would not come on. No patient involvement was reported. The light source will be returned for a new unit.

• 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: 11026884
• MDR Text Key: 222098718
• Report Number: 8010047-2020-10558
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/17/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/17/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: CLK-4
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/23/2020

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse