MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS XENON SHORT-ARC LAMP; ENDOSCOPE, ACCESSORIES, NARROW BAND

Model Number MD-631

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the device and found that the electrode of the md-631 seemed to be discolored due to high temperature.The high temperature was though to be due to insufficient application of the heat compound and/or inappropriate installation of the md-631.It would appear that the damage of the md-631 due to the high temperature caused the extinction of illumination, alternatively the spare lamp was lit and the error was displayed, and consequently the endoscopic image became dark.Based upon the finding of the evaluation, this report appears to be related to user handling.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during unspecified screening examination, the endoscopic image became dark and the error was displayed on the monitor.The facility completed the procedure with use of the similar but other system.It was found that the md-631 was burned-out.There was no report of the patient's injury regarding this event.

• Brand Name: OLYMPUS XENON SHORT-ARC LAMP
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4992872
• MDR Text Key: 23261689
• Report Number: 8010047-2015-00665
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-631
• Device Lot Number: PJ1735
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• 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