MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION WIRELESS RECEIVER

Model Number UWIT-RX

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The subjected device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the device but the reported phenomenon was not reproduced.In a state uwit-tx and uwit-rx are face-to-face horizontally, omsc switched the channels of uwit-tx and uwit-rx 500 times.But the reported phenomenon was not reproduced.In a state they are not face-to-face horizontally, omsc switched the channels of uwit-tx and uwit-rx 500 times.But the reported phenomenon was not reproduced.Omsc checked the device history record of the subject device, and there was no irregularity found.The uwit-tx and uwit-rx instruction manuals state the corresponding method when there is an abnormality in the endoscopic image.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.This report is one of two reports.Cross reference mfr.Report number 8010047-2015-01248.

Event Description

On (b)(6) 2015, olympus was informed the following information.During an unspecified procedure, the transfer of an endoscopic image from uwit-tx to uwit-rx connected to the sub monitor is interrupted.The facility replaced the uwit-rx and the monitor with spare devices and the physician completed the procedure.There was no report of the patient's injury regarding this event.

Manufacturer Narrative

Omsc evaluated the device continuously but the reported phenomenon was not reproduced.Omsc surmised that the cause of the phenomenon is the followings in theory.Factor 1 - the installation status of uwit-tx and uwit-rx is inappropriate.Uwit-tx and uwit-rx cannot communicate.Factor 2 - uwit-tx and/or uwit-rx go wrong.Uwit-tx and uwit-rx were not synchronizing.Factor 3 - under the influence of the external environment, uwit-tx and/or uwit-rx ran the system reset.Uwit-tx and uwit-rx were not synchronizing.Omsc checked this device, did not find any abnormality.Omsc checked the installation status of uwit-tx and uwit-rx in the facility.The distance between uwit-tx and uwit-rx was from 1 - 5 m, this is within the range of ifu.The direction of uwit-tx and uwit-rx was not slightly horizontal.Based on these and the investigation result of subject devices, omsc surmised that this phenomenon might be caused by "factor 3"."factor 3" might be caused by any of the following mechanisms.- the dcdc converter of uwit-tx and/or uwit-rx did not output the electric voltage enough, because an electric voltage supplied to the uwit-tx and/or uwit-rx changed and/or dropped suddenly.Uwit-tx and/or uwit-rx ran the system reset.As a result, uwit-tx and uwit-rx were not synchronizing.- the dvi-signal inputted to the uwit-tx was distorted by the influence of any disturbance noise.Uwit-tx detected this distortion, ran the system reset.As a result, uwit-tx and uwit-rx were not synchronizing.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.This report is one of two reports.Cross reference mfr.Report number 8010047-2015-01248.

• Brand Name: WIRELESS RECEIVER
• Type of Device: WIRELESS RECEIVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hchioji-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: 5301539
• MDR Text Key: 33587376
• Report Number: 8010047-2015-01260
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UWIT-RX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• 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