MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-10

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 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The subject device was powered for an hour, and the power was turned off and on, then the reported event was duplicated.Though a water leak test was performed, the leakage was not found.The manufacturing record of the device was reviewed without irregularity.The exact cause of the reported event could not be conclusively determined, but from the past evaluation, it is surmised that the circuit board of the video connector is broken, or starts to be broken.Since the sealing was applied on the circuit board of the video connector, further analysis, such as confirmation of the mounting parts, could not be conducted.If an overcurrent is applied to electrical contacts of the video connector due to such a phenomenon as electrostatic discharge, the mounting parts in the circuit may be broken.

Event Description

The user facility used the subject device for an esophagoscopy procedure.To change the patient body position, the scope was withdrawn from the patient and the power was turned off.After the position change, the power was turned on, but the endoscope image did not appear, and b32 error (scope malfunction) was displayed.Though the user facility reconnected the scope, the error was not reset, so the subject device was replaced with ltf-s190-5 and the procedure was completed.There was no patient injury reported.Even when the subject device was connected to another video system center, b32 (the endoscope is damaged) error occurred.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5705533
• MDR Text Key: 46784637
• Report Number: 8010047-2016-00660
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LTF-S190-10
• Device Catalogue Number: LTF-S190-10
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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