MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Component Missing (2306)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon inspection testing of the returned device, the user's request was not confirmed.The unit was found to function properly according to the technical guide.The air flow check passed inspections and met the specific requirements noted in the technical guide.It was noted the unit failed full inspection due to cosmetic damage and lamp replacement.The heatsink assembly was found to be missing a screw and a washer.In addition, the front panel was cracked, the chassis had sign of condensation, the power switch was sticking intermittently due to a foreign substance, there was dust buildup inside the unit, and a non-olympus lamp had 0 or more hours.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the evis exera iii xenon light source had low air flow during preparation for use for an unknown diagnostic procedure.The procedure was completed with the subject device without delay.There were no reports of patient harm associated with this event.Upon inspection and testing of the returned device, the heatsink assembly was missing a screw and a washer.The medical device report (mdr) is being submitted to capture the reportable malfunction of the heatsink assembly missing a screw and a washer found during evaluation.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.The legal manufacturer's investigation found the installed lamps were manufactured by other companies and the position of the screw holes were not in accordance with clv-190 standards which is likely the cause for the missing screw and washer.The initial medwatch reported that the heatsink assembly was missing a screw and a washer.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON 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: 14505935
• MDR Text Key: 300574757
• Report Number: 8010047-2022-08926
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/13/2022
• 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
• Patient Sequence Number: 1