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

Model Number GIF-1200N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Headache (1880); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 11/12/2023

Event Type  Injury  

Manufacturer Narrative

E1: (b)(6) (documented here in its entirety due to character limitations in respective field) the legal manufacturer has completed the final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The dhr confirmed that the subject device was released in accordance with the specifications.Since the device was not returned, the root cause of the reported event could not be determined.However, it was presumed that some kind of allergic reaction occurred.The instructions for use warns against improper reprocessing as follows.¿improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.¿ olympus will continue to monitor field performance for this device.

Event Description

It was reported that a patient developed mild anaphylactic shock with symptoms of headache and chest hives/urticaria after an upper endoscopy using the gastrointestinal videoscope.The patient was subsequently transferred and treated at the emergency department.The patient has a history of extreme metal allergy but insisted on having the test done against medical advice.Reportedly, a lot of research was done on this case and the endoscope nozzle on the tip of the endoscope was the only thing considered relevant.There were no device abnormalities noted.The device was also inspected prior to use without any issues.There was no further patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to g2 to include information that was inadvertently not included on the initial medwatch.

• Brand Name: 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: 18780112
• MDR Text Key: 336240558
• Report Number: 9610595-2024-03970
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-1200N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian