MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. XENON LAMP

Model Number MD-631

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the hysteroscopic surgery with clv-s190 using the device (xenon lamp md-631), there was a bursting sound and the device went off.The emergency lamp of the clv-s190 stated up.The user completed the procedure by using the clv-s190.There was no report of patient injury associated with the event.The device was broken.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed cracks over the entire surface of the lens of the subject device.Omsc confirmed that four years or more have passed since the subject device was manufactured.The exact cause of the reported phenomenon could not be conclusively determined.However, it is surmised that the reported phenomenon was attributed to an accidental failure or over heated due to dust on the heat exhaust of the light source.

• Brand Name: XENON LAMP
• Type of Device: XENON LAMP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11136527
• MDR Text Key: 238350665
• Report Number: 8010047-2021-01051
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1