MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA ELITE VIDEO SYSTEM CENTER OTV-S190; VIDEO PROCESSOR

Model Number OTV-S190

Device Problem Image Display Error/Artifact (1304)

Patient Problems No Consequences Or Impact To Patient (2199); Hernia (2240)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Olympus was informed that noise on the monitor screen occurred during laparoscopic hernia restoration.The facility replaced the subject otv-s190 to another system to complete the procedure.There was no injury report of this event except exchanging the device.

Manufacturer Narrative

The subject otv-s190 was returned to olympus for eval.Olympus could not confirm the phenomenon but there were foreign substances near the electrical contact of the video connector socket.Olympus could reproduce this phenomenon by connecting a scope to the otv-s190, placing foreign substances on the scope connector pins for insulation.This phenomenon might be attributed to conduction failure between the scope and the otv-s190 because adhesion of foreign substances inside the video connector socket or water on the scope connector might interrupt connection between the two devices temporarily.Olympus also checked the mfg history of the subject device, and there was no irregularity found.The instructions manual already stated notifications of electrical contact handling.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER OTV-S190
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 195- 8507; JA 195-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4812373
• MDR Text Key: 5917754
• Report Number: 8010047-2015-00371
• Device Sequence Number: 1
• Product Code: LLZ
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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?: Yes
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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