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

Model Number GIF-H190

Device Problem Failure to Clean Adequately (4048)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

The customer reported a stent got stuck inside the instrument channel of the gastrointestinal videoscope.The scope was removed from the patient and the procedure was successfully completed.The scope was then sent for reprocessing and not removed from circulation at the site.The scope was used in a second diagnostic and therapeutic esophagogastroduodenoscopy with dilation procedure.During the second procedure, a retrieval balloon was passed down the scope and the stuck stent was dislodged and fell into the patient.No medical intervention was required and the site confirmed there was no patient infection.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the following: labels not properly affixed; leaks in contact pins; leaks in instrument channel; leaks in air/water channel; restriction through channel; upwards is low; knob has a play; distal end plastic cover has dents; bending section cover or distal sheath rubber had a crack; insertion tube has buckles affecting internal elements; control body missing color rings; and light guide tube has buckles.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (a4, a5, b7, and d10).Additionally, to provide information received through follow up b5.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, it is possible the reported malfunction occurred due to multiple kinks on biopsy channel, the non-olympus stent was not removed at reprocessing after procedure a and was not detected at inspection prior to use.Subsequently, the stent which remained in biopsy channel of the subject device came out of the device by stress while inserting balloon during procedure b.However, a specific root cause of the reported malfunction could not be determined.Additionally, the relationship between the non-olympus stent and balloon dilatator that were used with the subject device is unknown.The event can be detected by following the instructions for use which state: - operation manual: 3.8 inspection of the endoscopic system: inspection of the instrument channel olympus will continue to monitor field performance for this device.

Event Description

It was reported that there were no malfunction of reprocessing accessories and no delay to pre-cleaning or manual cleaning.The user aspirating water/detergent during pre-cleaning.The channels, port, and suction cylinder was brushed.The subject device was inspected prior to use.It appears that the stent was stuck in the working channel.Normal reprocessing steps were complete.The stent came out when the balloon device was inserted.Additionally, the boston representative reported, that the advanix biliary double pigtail 7 fr.2.33mm stent would fit down a 2.8 channel scope.

• 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: 18229896
• MDR Text Key: 329270835
• Report Number: 9610595-2023-18272
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• 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
• Treatment: ADVANIX BILIARY DOUBLE PIGTAIL STENT.; BALLOON DILATATOR.
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White