MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA PRO VIDEO SYSTEM CTR

Model Number OTV-S7PRO

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Olympus was informed that during the laparoscopic low anterior resection of the endoscopic image had disappeared.The facility had cycled the power of the otv-s7pro, but the endoscopic image had not been displayed on the monitor.The facility had completed the procedure with use of the other otv-s7pro.There was no report of the pt's injury regarding this event.

Manufacturer Narrative

The otv-s7pro referred to was returned to the olympus med systems corp (omsc) for eval.The eval confirmed the user's report, but could not identify the cause of this phenomenon.There was no abnormality and/or irregularity of the exterior of the device.Also, omsc checked the mfg history of the subject otv-s7pro and found no irregularity.Omsc stated the appropriate handling of the otv-s7pro in the instruction manual when the otv-s7pro had abnormalities.There were no further details provided.If significant additional 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: VISERA PRO VIDEO SYSTEM CTR
• 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: 4368728
• MDR Text Key: 19763236
• Report Number: 8010047-2014-01140
• 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: Physician
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• 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?: Yes
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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