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

Model Number OTV-S7PRO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.Olympus checked the subject device, and there was no abnormality of the subject device.The cause of this defect was not conclusively determined at this time.There were no further details provided at this time.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files:mfr report# : 8010047-2016-00737.

Event Description

During an open surgery, the facility used the subject otv-s7pro for observation of the operational field and recording the images.Upon connecting a camera head, otv-s7pro-hd-e12 to otv-s7pro, a malfunction of the whole image turning green occurred periodically.The facility attempted to turn the power switch on and off but the device did not come to normal.The procedure was completed by replacing the subject otv-s7pro to cv-190.No health damage to the patient was reported other than replacing the device.In response to the failure, they had been substituted for the olympus-owned otv-s7pro and otv-s7proh-hd-e12 later.However, the similar phenomenon occurred again.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2016-00736 to provide device evaluation results.Olympus could reproduce this phenomenon by inserting the user's pc card adapter to the subject device.Olympus could confirm the dent in a connecter part of the user's pc card adapter.While the pc card adapter is inserted in otv-s7pro, otv-s7pro carries out a start process cyclically.The inside of user's pc card adapter was damaged from the dent.Therefore, olympus considered the image becomes green at start process cyclically.The instruction manual of otv-s7pro already mentions cautions for the device handling.There were no further details provided at this time.If significant additional information is received, this report will be supplemented.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 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: 5696649
• MDR Text Key: 46472229
• Report Number: 8010047-2016-00736
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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: OTV-S7PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2010
• 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