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

Model Number CLK-4

Device Problem Material Disintegration (1177)

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

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center follow up with the customer regarding the reported event and was informed that the unit damage was not caused from being dropped but it is believed that the unit was chemically damaged by the cleaner used to wipe the housing and switch area.The unit was not used in procedures but used to air test scopes and check the optics of the facility's scope.There was no other issue noted with the unit.In addition, the unit was returned to the service center for evaluation.The customer¿s complaint of ¿front case is broken away and switch is being held in by zip ties¿ was confirmed.The front panel found was damaged with power switch pushed out.In addition, corrosion was noted on the bottom chassis.The power switch on the front of the unit was damaged.The spare lamp failed to come on due to a faulty lamp.The unit¿s air pressure was low due to a faulty air pump unit.The air joint unit, mount and connector socket were noted to be worn.The units other function were normal.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during maintenance, the front case of the unit broke away and the switch held in with zip ties.There was no patient involvement and no user/patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: additional information from users suggests that the damage to the unit was not due to dropping, and that the unit was considered to have been chemically damaged by a cleaner used to wipe the surface and switch parts.Therefore, we assume that the deterioration was promoted by the wrong cleaning method, leading to the occurrence of the phenomenon.It is assumed that the spare lamp has exceeded its expected service life or does not light up due to corrosion of the harness part due to repeated use for a long period of time since the device was manufactured for more than 15 years.The legal manufacturer confirmed contents described in the instruction manual.Handling of the device is described below in the instruction manual.As a result, there is a possibility that can be prevented.Do not autoclave or gas sterilize the equipment.Since the device in question was manufactured more than 15 years ago, it is not possible to confirm the record.

• 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: 11897900
• MDR Text Key: 269750300
• Report Number: 8010047-2021-06816
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLK-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1