MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.An issue was noted with the air/water channel.A deep cut was observed was on the pink rubber of the scope¿s probe.The bending section rubber was cut and the bending section.The bending section braid was found frayed 7 plus strands were noted to be broken.The cement was peeling on the scope¿s objective and guide lens.The scope¿s image was foggy and 5 elements were noted to broken in the ultrasound image.Fluids were noted the control body and scope connector.The light guide tube was found to be buckled.The ultrasound cord was collapsed.Further inspection found play on the scope¿s control knob and its movement was loose.

Event Description

The service center was informed that during reprocessing, the scope elevator lever would not go down.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.More then 5 years have passed since the subject device was manufactured.Based on the results of the investigation, the likely causes are as follows: missing glue and cut on probe unit: it is likely due to aging deterioration or due to an external force (such as strong rubbing against the relevant part during normal use, including reprocessing).Forceps elevator is not sitting properly: it is likely an excessive force applied caused an extension of the wires that perform the forceps rise-up table manipulation.The instructions for use include the following which can detect the event: "inspection of the endoscope: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.".Per the legal manufacturer, the other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10881755
• MDR Text Key: 225653819
• Report Number: 8010047-2020-09292
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1