MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MD-631 (Y1064ST) XENON LAMP

Model Number MD-631

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The subject md-631 was returned to omsc for the evaluation.Omsc checked the subject md-631 and found the following.-the subject md-631 in the clv-s190 had the small crack on the surface.Omsc surmised that this phenomenon might have occurred by following.-the light quantity of the subject md-631 became lower because the xenon gas in the subject md-631 leaked from the crack on the surface.The light quantity of the subject md-631 was equivalent to the emergency lamp of the clv-s190.The user recognized that the emergency lamp ignited.Md-631 instruction manual states the corresponding method in case of an abnormality.There were no further details provided.If significant additional information is found, this report will be supplemented.

Event Description

The emergency lamp of the clv-s190 ignited during unspecified procedure.The user replaced the clv-s190 with another clv-s190 and completed the procedure.There was no report of the patient¿s injury regarding this event.Olympus medical systems corp.(omsc) investigated the clv-s190 in nov 16, 2017.Based on the investigation result, omsc surmised that the subject md-631 might have been related to this phenomenon.

Manufacturer Narrative

This supplemental report is submitted to correct "device product code.".

• Brand Name: MD-631 (Y1064ST) XENON LAMP
• Type of Device: XENON LAMP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7098864
• MDR Text Key: 95763923
• Report Number: 8010047-2017-01953
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: MD-631
• Device Lot Number: ¿¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1