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

Model Number OTV-S7PRO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Liver Damage/Dysfunction (1954)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is not returned to olympus yet.Olympus will investigate the subject device to determine the cause of this phenomenon when olympus receives it.There were no further details provided.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00106.

Event Description

Olympus was informed that a monitor image became purplish during the laparoscopic cholecystectomy with the subject device and the laparo-thoraco videoscope ltf-vh.The facility continued to use the subject device and the ltf-vh, and the procedure was completed.After the procedure, bile spillage occurred.The facility performed an open surgery because there was no alternate device at that time.The facility commented the image difficulty might cause the bile spillage.The ltf-vh was suspected to have malfunction at first, so olympus checked the ltf-vh on (b)(6) 2016.But there was no abnormality of the ltf-vh.After that, the phenomenon occurred again when the facility used the subject device connected with another scope.Therefore, the subject device might be attributed to the cause of this phenomenon.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2016-00237 to provide device evaluation results.The subject device was returned to olympus for evaluation.Olympus checked the subject device but the reported phenomenon was not reproduced.Olympus will continue to investigate the cause of this phenomenon.Olympus also checked the device history record of the subject device, and there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00106.

Manufacturer Narrative

Omsc tried to reproduce the phenomenon with the subject device and the endoscope that the facility own, and the phenomenon was reproduced.Omsc investigated the behavior of the video signal processing about the subject device, but omsc could not find any abnormality.Omsc is investigating about this issue.There were no further details provided.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files: mfr report #: 8010047-2016-00106.

Manufacturer Narrative

Omsc investigated the behavior of the video signal processing.The subject device did not have any abnormality.Omsc evaluated the endoscope that the facility own, and found that the timing of the video signal processing of this endoscope deviated from the standard.As a result of these investigations, omsc concluded that this phenomenon did not cause by the subject device, and surmised that the malfunction of the endoscope caused this phenomenon.Please cross reference the associated complaint files: mfr report #: 8010047-2016-00106.

• 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: 5409599
• MDR Text Key: 37425880
• Report Number: 8010047-2016-00237
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• 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: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2009
• 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): Other
• Patient Age: 54 YR