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

Model Number LTF-S190-5

Device Problems No Display/Image (1183); Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported that during maintenance of an endoeye flex deflectable videoscope, the image was blacked out and the bending rubber would not bend.No patient involvement or impact to patient care was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information collected from the customer's response, device evaluation, and the legal manufacturer's final investigation.The device was returned to olympus for evaluation and the service center confirmed the customer's complaint.The image problem was caused by a faulty charge-coupled device (ccd).The device was repaired and returned to the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the event occurred due to one of the following: breakage of ccd cable: caused by excessive bending or pulling stress applied to the bending section and/or the universal cord.Short-circuit of ccd cable: caused by wrong routing of the connector circuit board.Insulation breakdown inside ccd due to overcurrent: caused by either the video system center not connected, connection or disconnection of the scope connector while the video system center is turned on, adhesion of stain or moisture to the electrical contacts of the video connector the instructions for use have the following statement which can prevent the event: "do not strike, hit, or drop the endoscope's distal end, rigid portion, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope's distal end, rigid the endoscope may be damaged and could cause patient injury, burns, bleeding, and / or perforations.It could also cause parts of the endoscope.To fall off inside the patient." "do not insert the video connector while the electrical contacts are wet and / or dirty, which may result in an electric shock, causing severe damage to the endoscope and compromising patient and / or operator safety." "turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor." per the legal manufacturer, the bending rubber would not bend included in the initial mdr has no potential to cause or contribute to death or serious injury if the malfunction was to recur.

• 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-to 192-8 507; JA 192-8507
• MDR Report Key: 11372717
• MDR Text Key: 233356934
• Report Number: 8010047-2021-02952
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1