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

Model Number GF-UCT180

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.The customer¿s complaint of ¿ nbi button not working¿ was not confirmed.The scope¿s control body was inspected and found the pink rubber chipped.The bending section rubber glue was found chipped and cracked.A leak was noted at scope¿s auxiliary water flow inlet.The elevator channel inlet was found loose.Fluid invasion was noted in the scope¿s control body, scope connector and ultrasound connector.The scope¿s id chip shows 685 uses.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed during an unspecified procedure, the scope¿s narrow band imaging (nbi) button was not working.It is unknown if the intended procedure was completed.There was no patient injury.

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.Based on the results of the investigation, it is likely some external force was added to the distal end, leading to the peeling of the glue at the tip.In addition, about 8 years and 7 months have passed since the device was manufactured and it may have been affected by aging degradation.The instructions for use have the following statement which can detect the event: "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.".

• 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: 11310317
• MDR Text Key: 233830740
• Report Number: 8010047-2021-02501
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1