MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-2TH180

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.Therefore, it is unknown if there was any foreign object or material that caused the reported "blockage" during the reported procedure, if damage to the scope caused the "blockage" or if there was "blockage" from a previous procedure.The scope was returned tp the service center.Upon inspection and testing, the reported "blockage" was confirmed at the distal end side of the instrument channel.However, there was no report of foreign object/material exiting the channel.A deep buckle was observed near bending section on the insertion tube.Additionally, the scope failed the leak test from a cut/leak at switch button# 1.The bending section cover glue was cracked.The control knob movement has play/loose and the distal end plastic cover is damaged and requires a replacement.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The olympus service center was informed by the onsite support specialist was informed that there was "blockage in the channel" of the customer's evis exera ii gastrointestinal videoscope was observed during an unspecified procedure.There was no patient injury or harm reported.The scope will be returned for service.

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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the cause of the blocked channel was likely from one of the following events: pre-cleaning was not performed immediately after procedure which caused the material difficult to remove, water flow was not enough at pre-cleaning and/or manual cleaning which caused the material difficult to remove or device handling deviated from instructions for use which caused the insertion section to flatten.The specific root cause could not be determined at this time.The following information is stated in the instructions for use regarding reprocessing: ¿if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside in the patient procedure.Chapter 5 flush the auxiliary water channel says that the auxiliary water channel must be flushed".The following information is stated in the instructions for use regarding user handling: ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12685940
• MDR Text Key: 278135427
• Report Number: 8010047-2021-13557
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339745
• UDI-Public: 04953170339745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1