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

Model Number LTF-S190-5

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The device was returned to the service center and is pending evaluation.The cause of the reported event cannot be determined at this.

Event Description

The service center was informed that during an unspecified procedure, the device image went black.The device had to be unplugged and reconnected and then the image would reappear.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the event date and additional information.Please see the updates in sections: b3, g4, g7, h2 and h10.Additional information received from the user facility states it is unknown how the image was able to be stored.The device was inspected.There were no abnormalities or damage noted.It is unknown if the examination lamp was old.It is unknown if the endoscope or light guide was connected to the output socket.It is unknown if the device was connected properly.It is unknown if the video system center was on.No foreign objects such as detergent remnants, hard water residue, dust or lint were on the electrical contacts.The cord was not coiled, bunched or kinked.It is unknown if the device was connected properly or if the connection was secure.It is unknown how the device is reprocessed.It is unknown how the device is stored.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results and additional information from the legal manufacturer.The device was returned to the service center for evaluation.The customer¿s complaint of "image issue" was confirmed.An intermittent image was noted downward.The video cable was found to be cut or have a hole causing a leak.There were scrape marks at noted on the bending section rubber with missing rubber at distal end.The scope¿s braid had 10 plus frayed wires.The legal manufacturer reviewed the contents of this complaint.The legal manufacturer reported that as the result of dhr review, the product was shipped in accordance with its specifications.The legal manufacturer reported that the probable cause for the reported event was as follows: according to investigation result 1-3, it was assumed that the reported event was caused because the imaging cable incorporated into the bending section was buckled/broken.Because the scrape in the a rubber of the actual item was confirmed and the bending wire was frayed, it was assumed that the buckling/breakage of the imaging cable might have been caused by interference between the bending segment and the imaging cable inside the bending section resulting from stress applied to the bending section during insertion and withdrawal to/from the trocar.(assumed to be the same as the similar complaint indicated in investigation result 2-3, 2-4).

• 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: 10463347
• MDR Text Key: 223510105
• Report Number: 8010047-2020-05955
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 08/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1