MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS VISERA XENON LIGHT SOURCE

Model Number CLV-S45

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Olympus was informed that the monitor became dark and the image turned red during the laparoscopic appendectomy.The facility converted the procedure to an open surgery and completed it.The patient is doing well after the open surgery.

Manufacturer Narrative

Olympus confirmed that the spare lamp on the subject clv-s45 lighted up when the subject device was turned on.The subject device worked properly to replace the subject xenon lamp to another one.The subject xenon lamp lighted up when being equipped with another clv-s45.Olympus checked the igniter unit and the xenon lamp suspected as the cause of this phenomenon in detail, but there was no abnormality in these parts so far.Olympus also checked the manufacturing history of the subject device, and there was no irregularity found.The issue is under investigation, so olympus will submit a supplemental mdr report after the cause of this phenomenon is determined.This report is being submitted as a medical device report in an abundance of caution.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2015-00577 to provide device evaluation results.As for the further investigation for this phenomenon, olympus confirmed that the subject xenon lamp turned on properly after the xenon lamp and the igniter unit were mounted on a spare clv-s45.Olympus could not determine the cause of this phenomenon because the phenomenon was not reproduced.The phenomenon might be attributed to lighting failure by temporary improper behavior of the igniter unit or to voltage boost failure by humidity and atmospheric pressure in the facility.In addition, lamp supply voltage from the convertor of the subject device might drop, or supply voltage of the subject device might lower due to the facility surroundings.The instruction manual of clv-s45 already mentions cautions for the device 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: OLYMPUS VISERA XENON LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 4914624
• MDR Text Key: 6435768
• Report Number: 8010047-2015-00577
• Device Sequence Number: 1
• Product Code: GCT
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CLV-S45
• Device Catalogue Number: CLV-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 60