MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS VISERA ELITE VIDEO SYSTEM CENTER; GYNECOLOGIC LAPAROSCOPIC AND ACCESSORIES

Model Number OTV-S190

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 06/16/2014

Event Type  malfunction  

Event Description

Olympus was informed that during the laparoscopic cholecystectomy procedure and endoscopic image had disappeared.The facility had cycled the power of the otv-s190, but the endoscopic image had not been displayed and the color bar signal and/or error had been displayed on the monitor.The facility had completed the procedure with use of the other system.There was no report of the pt's injury regarding this event.

Manufacturer Narrative

The referenced otv-s190 was returned to olympus medical systems corp (omsc) for eval.Omsc evaluated the otv-s190 and the endoscope which was used in conjunction with the otv-s190 and found that the abnormal image and/or noisy image were displayed, also the error appeared on the monitor.Furthermore, the locking lever of the otv-s190 was deformed and there were a lot of lint on the electrical contacts of the video connector.Olympus attributed this phenomenon to inappropriate handling of the device by user.The otv-s190 instruction manual states the notice for the handling of the device.Also, omsc checked the mfr history of the subject device, there was no irregularity found.There were no further details provided.If significant add'l 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: OLYMPUS VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: GYNECOLOGIC LAPAROSCOPIC AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; 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: 4030287
• MDR Text Key: 4841635
• Report Number: 8010047-2014-00384
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2014

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-S190
• Device Catalogue Number: OTV-S190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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