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

Model Number GIF-HQ190

Device Problem Mechanical Jam (2983)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the distal end channel opening and biopsy port opening were free of residue and foreign material.The biopsy channel and suction channel were clear of debris and a brush and forceps was passed through the channel without issue.The device was then tested with an olympus single use reloaded clip adapter with a short ez clip attached.When reaching the distal end, the device would not pass through, which confirmed the allegation.The biopsy channel was inspected with a borescope and adhesive was found around the channel pipe causing the ez clip not to pass through.There were also minor scrapes and tears in the biopsy channel.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the ez clip could not be passed through the channel of the evis exera iii gastrointestinal videoscope.The clip got stuck at the distal end side and not the channel port side.The issue occurred during a therapeutic endoscopic submucosal dissection (esd) procedure.There is typically bleeding during an esd and the physician wanted to clip to make sure after coagulating.The physician also wanted to clip after dissection.The procedure took about 1.5 hours and the delay due to the ez clip was less than 5 minutes since the physician immediately switched to a clip from another manufacturer.The procedure was completed without issue.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found that there was glue around the channel pipe causing the ez clip not to pass through.The report is being submitted due to the defect found during evaluation.

Event Description

Although additional details regarding the customer¿s procedure for handling and reprocessing the scope were requested, no further details were provided.However, it was reported that the subject scope was used in a ¿live¿ case, but since it was an olympus asset device, it was reprocessed by an olympus endoscopy support specialist (ess).

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 11 years since the subject device was manufactured.Based on the results of the investigation, the clip could not pass through the biopsy channel because a glue-like foreign material adhered to the inside of the channel.However, the specific foreign material could not be identified.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿operation manual preparation and inspection of the endoscopic system inspection of the instrument channel¿ ¿operation manual operation using endotherapy accessories insertion of endotherapy accessories into the endoscope caution: do not open the tip of the endotherapy accessory or extend the tip of the endotherapy accessory from its sheath while the accessory is in the instrument channel.¿ this supplemental report includes additional details received.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: 17975005
• MDR Text Key: 326143079
• Report Number: 9610595-2023-15563
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• 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