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

Model Number GIF-HQ190

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the gastrointestinal videoscope sclero needle and glue was stuck in channel.The issue was found during a therapeutic procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found: labeling - peeling connector labels, brush passage - no pass, scope leak check - unable to perform due to clogged channel, c-cover insulation - megaohm value, forceps passage - clogged bx (biopsy) channel, angulation - d=60, l=70, r=80, u160, control knob movement - play-loose, d/e plastic cover - chip and scratches, a-rubber glue - cracked, insertion tube ¿ buckle, air water supply - unable to perform due to clogged channel, auxiliary water flow - unable to perform due to clogged channel, suction flow - unable to perform due to clogged channel, light guide tube - buckle.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the results of 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 could not be determined.The foreign material could not be conclusively identified and the cause of the material remaining in the device could not be specified.There was no damage to the area where the foreign material was detected and it is unknown if reprocessing was performed according to the instructions for use (ifu).Three attempts were performed to obtain additional information, but no response was received from the customer.The event can be detected and prevented by handling the device in accordance with the following ifu: gif/cf/pcf-190 series operation manual chapter 3 "preparation and inspection" shows how to detect the event.Gif/cf/pcf-190 series reprocessing manual chapter 5 "reprocessing the endoscope" shows how to prevent the event.Olympus will continue to monitor field performance for this device.

• 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: 18370512
• MDR Text Key: 331116483
• Report Number: 9610595-2023-20053
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• 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