MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA ELITE VIDEO SYSTEM CENTER; ENDOSCOPE, ACCESSORIES

Model Number OTV-S190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/04/2015

Event Type  malfunction  

Event Description

Olympus was informed that during the laparoscopic assisted distal gastrectomy (ladg) the endoscopic image had disappeared several times in a short time.The facility changed the otv-s190 other device and completed the procedure.There was no report of the patient's injury regarding this event.

Manufacturer Narrative

The referenced otv-s190 was returned to the olympus medical systems corporation (omsc) for evaluation.The evaluation could not confirm the user's report, however the otv-s190 had records of the multiple power shutdown in a short period of time.It would appear that this phenomenon was attributed to temporary electrical power fluctuation of the facility.Also, omsc checked the manufacture history of the subject otv-s190, there was no irregularity found.Osmc stated the appropriate handling of the otv-s190 in the instruction manual when the otv-s190 had abnormalities.There were no further details provided.If significant additional information is received, this report will be supplemented.This report appears to be related to user handling.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: ENDOSCOPE, ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 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: 4631897
• MDR Text Key: 5757195
• Report Number: 8010047-2015-00202
• Device Sequence Number: 1
• Product Code: NWB
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• 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: 03/10/2015
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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