MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION VISERA ELITE VIDEO SYSTEM CENTER; VIDEO PROCESSOR

Model Number OTV-S190

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device and concomitant the ltf-s190-10 were returned to olympus for evaluation.Olympus confirmed the subject device worked properly.Although the subject device connected to the ltf-s190-10, the reported phenomenon could not be reproduced.The subject device worked properly after the user facility replaced the ltf-s190-10 to another videoscpe.So there was a possibility that contact failure between the subject device and the ltf-s190-10 might occur temporarily due to adhesion of foreign substances on the electrical contact of the video connecter in the ltf-s190-10.Olympus also checked the device history record of the subject device, and there was no irregularity found.The instruction manual of otv-s190 and ltf-s190-10 already cautions for video connector handling.There were no further details provided at this time.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.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00232.

Event Description

The monitor image became noisy when the user facility checked the image from the endoeye flex deflectable videoscope ltf-s190-10 in preparation for the procedure after the patient was anesthetized.The user facility turned off and on the subject device, and disconnected and connected the video connector to the subject device.However, the phenomenon still occurred.The facility completed the procedure with replacing the videoscope to another videoscope.There was no report of patient injury in this event.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5455847
• MDR Text Key: 38856778
• Report Number: 8010047-2016-00336
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2012
• 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
• Treatment: LTF-S190-10