MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUYS 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 06/01/2015

Event Type  malfunction  

Event Description

Olympus was informed that during the withdrawal of the endoscope from the patient on the gastroendoscopy, the endoscope image became dark with a loud noise.The physician continued to perform the procedure and completed the procedure as it is.There was no report of the patient's injury regarding this event.

Manufacturer Narrative

The referenced device was returned to olympus medical system corp.(omsc) for evaluation.Omsc evaluated the device and found that the surface glass of the md-631 was broken and the pieces of the glass were dropped into the inside of the light source.It would appear that the damage caused the extinction of the md-631, alternatively the spare lamp was lit, and consequently the endoscopic image became dark.Also, it would appear that the loud noise occurred when the md-631 was broken.Based on the similar cases with the same model, it is known that by inappropriate handling of the md-631 such as the adhesion of the foreign object on the surface glass, strong impact, and/or not secured installation, the md-631 gets broken.The manufacturing history was reviewed, with no irregularities noted.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.

• Brand Name: OLYMPUYS XENON SHORT-ARC LAMP
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 1492 -850; JA 1492-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507
• MDR Report Key: 4905445
• MDR Text Key: 6071786
• Report Number: 8010047-2015-00593
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-631
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• 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