MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS XENON SHORT-ARC LAMP; XENON LAMP

Model Number MD-631

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service department of the overseas subsidiary of olympus for evaluation.This device will return to olympus medical systems corp.(omsc) for evaluation.Omsc has not yet received this device.The service department of the overseas subsidiary of olympus investigated it.The glass part of the md-631 was broken.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

The facility performed the endoscopy with the clv-u20 in which the md-631 is mounted.During this examination, the light by the md-631 went out.The facility replaced the clv-u20 with a spare light source and completed the examination.There was no report of the patient's injury regarding this event.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and confirmed that the glass part has a crack.Omsc confirmed that the lot no.Of the subject device is qg1191.Omsc checked the device history record of the subject device, and there was no irregularity found.Omsc surmised that the cause of this event is the following in theory.By the influence of the unintended temperature rise, the thermal stress was applied to the glass part.The crack occurred in the glass part by this thermal stress.The xenon gas of this lamp leaked from this crack.As a result, the light by the md-631 went out.Omsc surmised that the factor of the unintended temperature rise is the following.The vent of the clv-u20 was blocked.So the internal temperature of clv-u20 became high.Any foreign material (e.G.A compound) had attached to the glass part.So the temperature of the part where the foreign material was attached became high.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.

• Brand Name: OLYMPUS XENON SHORT-ARC LAMP
• Type of Device: XENON LAMP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 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 ; 2 6425177
• MDR Report Key: 5569333
• MDR Text Key: 42386038
• Report Number: 8010047-2016-00505
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• 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: QG1191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• 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
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 78