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

Model Number GF-UCT180

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the olympus service center.The evaluation found the adhesive at the distal end forceps cover was peeled off.Additionally, the adhesive at the bending section cover were missing and failed the leak test.There were third party repairs / parts performed on the bending section cover and the insertion tube.Additionally, the objective lens and light guide lens at the distal end were cracked.The ultrasound image has multiple broken elements.The scope was repaired to standard specifications and returned to the customer.The scope was last repaired on (b)(6) 2018 due to a loose air/water connector issue).The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The user facility reported that during reprocessing, the evis exera ii ultrasound gastro-videoscope was noted to have a hole in the distal end.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause could not be conclusively specified.The probable cause of the peeling of the glue on the distal end occurred because some external force was applied to the distal end.In addition, due to the age of the product, it is unknown whether it was affected by aging deterioration.The ifu (instruction for use) provides guidelines for preparation and inspection: 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.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the customer and to update the following sections: g4, g7, h2, h6 and h10.The nurse manager at the user facility further reported that the problem was first noticed during reprocessing after a therapeutic endoscopic ultrasound procedure.There was no delay in the procedure and the procedure was completed with the same device.There was no patient injury, infection or medical intervention associated with this event.The scope was washed and high level disinfected.The device was inspected prior to use and no abnormalities were noted.

• 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: 11228587
• MDR Text Key: 229476311
• Report Number: 8010047-2021-01884
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• 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,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1