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

Model Number GF-UCT180

Device Problems Crack (1135); Display or Visual Feedback Problem (1184); Peeled/Delaminated (1454); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The evaluation could not reproduce or confirm the user report of air leakage/unable to insufflate.However, the evaluation found the forceps cover glue peeling, the rubber glue on the distal sheath cracked, and a broken element in the ultrasound image.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported that an evis exera ii ultrasound gastrovideoscope was having air flow issues.Per the customer report, the "air button leak(ed), not insufflating." as reported, there was no patient harm or impact to patient care due to this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of this investigation a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause was not established.Possible causes of the identified damage include external forces leading to peeling and damaging the distal end tip as well as aging due to the product being 2 years and 9 months old.The following statements are included in the ifu: "chapter 3 preparation and inspection: 3.2 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." olympus will continue to monitor the field performance of this device.

• 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: 11211383
• MDR Text Key: 228242637
• Report Number: 8010047-2021-01703
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1