MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-1TH190

Device Problems Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017); Failure to Clean Adequately (4048)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

A customer reported problems with feeding liquid through the forceps channel after using glue on the evis exera iii gastrointestinal videoscope.There were no reports of patient harm.Upon inspection and testing of the unit, foreign material was discovered on the channel cover and camera cover, and foreign material was stuck in the channel.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to an olympus repair facility and an evaluation of the device was performed.Upon inspection and testing of the unit, foreign material was discovered on the channel cover and the camera cover, and foreign material was stuck in the channel, caused by insufficient or incorrect reprocessing.Additional information was provided by the customer.During a gastroscopy on a patient with gastric fundus varices, there was a need for treatment with glubran surgical adhesive.The operating physician mistakenly retracted the sclerosis needle into the operative canal, and this caused the problem of canal occlusion.The needle was accidentally inserted into the forceps channel and the adhesive came out, clogging the channel.Additional evaluation findings included a scratched grip, a scratched forceps channel port, discolored aw-cylinder and s-cylinders; scratches on the switch box, right/left knob, sc cover unit, sc-case unit, the light guide cover glass, and the plug unit.The angulation play was out of specification.The light guide lens was cracked and scratched, and the connecting tube and universal cord had peeling coating.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the customer.

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, the root cause of the event was unable to be identified; however, it was confirmed that the customer had used medical adhesives in the previous case which adhered to the channel-cover and forceps channel.The event can be detected/prevented by following the instructions for use (ifu) which is described in olympus gif-1th190 operation manual chapter 3 preparation and inspection describes the detection method.The ifu states, "when using an injector, be sure not to extend or retract the needle from the catheter of the injector until the injector is extended from the distal end of the endoscope.The needle could damage the instrument channel if extended inside the channel, or if the injector is inserted or withdrawn while the needle is extended." olympus will continue to monitor field performance for this device.

Event Description

Additional information indicates that the event occurred during a procedure on (b)(6) 2023.During performance of gastroscopy in a patient with gastric fundus varices, there was a need for treatment with glubran, mistakenly the operating doctor retracted the sclerosis needle into the operative canal and this caused the problem of canal occlusion.The instrument is always inspected, checked and tested before the procedure, no abnormalities were found.The instrument after the event was replaced by another similar instrument to finish the procedure, there were no delays in the procedure.There was no need to administer additional drugs and/or lengthen the procedure.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17050191
• MDR Text Key: 317063939
• Report Number: 9610595-2023-08323
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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