MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA ELITE XENON LIGHT SOURCE; ENDOSCOPE, ACCESSORIES

Model Number CLV-S190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/02/2015

Event Type  malfunction  

Event Description

Olympus was informed that during the laparoscopic nephrectomy the endoscopic image became dark gradually.The facility changed the clv-s190 to another device and completed the procedure.There was no pt's injury regarding this event reported.

Manufacturer Narrative

The referenced clv-s190 was returned to the olympus medical systems corporation (omsc) for eval.The eval could not confirm the user's report, however the dust of gauze was found on the aperture unit.It would appear that this phenomenon was attributed to temporary electrical loss for the iris unit because of the dust.Omsc stated the iris handling of the clv-s190 in the instruction manual when the clv-s190 had abnormalities.There were no further details provided.If significant additional info is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: ENDOSCOPE, ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4616970
• MDR Text Key: 5594548
• Report Number: 8010047-2015-00239
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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