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

Model Number GIF-Q260J

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 11/21/2023

Event Type  Injury  

Event Description

The customer reported that when using an evis lucera gastrointestinal videoscope, there was fire at the plastic distal end cover causing burns to the patient¿s stomach.The event occurred during the pre-labeling phase of a therapeutic procedure (esd) and the c02 air pump was used to supply the gas at the time of the incident.There was no procedural delay, or no further patient harm reported with the event.The procedure was finished with another set of device.The patient was hospitalized for further treatment.Additional information regarding the event has been requested but not received at this time.This event requires three reports, as all devices were used during the event: patient identifier (b)(6) is for the videoscope.Patient identifier (b)(6) is for the electrosurgical knife.Patient identifier (b)(6) is for the hf unit.

Manufacturer Narrative

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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, a relationship between the subject device and the reported adverse event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: operation manual: chapter 4.Operation high frequency cauterization treatment.¿if the intestines contain a flammable gas, replace it with air or a non-flammable gas such as co2 before performing high frequency cauterization treatment.Otherwise, fire or explosion could result.¿ ¿never emit high frequency current before confirming that the distal end of the high frequency endo-therapy accessory is in the endoscope¿s field of view.Also confirm that the electrode section and the mucous membrane in the vicinity of the target area are at an appropriate distance from the distal end of the endoscope.If the high frequency current is emitted while the distal end of the endo-therapy accessory is not visible or too close to the distal end of the endoscope, patient injury, bleeding and/or perforation as well as equipment damage can result.¿ olympus will continue to monitor field performance for this device.

Event Description

The ¿pre-labeling phase¿ of the endoscopic submucosal dissection (esd) procedure was clarified as the phase when the physician marked the area of infection on the patient(pre-procedure).

Manufacturer Narrative

This supplemental report is being submitted to provide the results from the device evaluation.The physical device evaluation was performed by the repair center and results were reviewed by the legal manufacturer (lm).There were no reportable device defects observed.Therefore, there are no changes in the previously reported lm investigation findings.This supplemental report includes an update to d9 and h3 from the initial medwatch.

• Brand Name: EVIS LUCERA 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: 18335978
• MDR Text Key: 330608901
• Report Number: 9610595-2023-19664
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K222584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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: ELECTROSURGICAL KNIFE; HF UNIT "ESG-400"
• Patient Outcome(s): Hospitalization