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

Model Number GIF-H290T

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that three days after a therapeutic rectal endoscopic submucosal dissection (esd) procedure had been performed, the patient condition deteriorated and when a large intestine examination was performed, it was discovered that blood had accumulated in the intestinal membrane of the large intestine (location unknown).It is unknown whether this was the cause of the deterioration of the patient's condition.No further information about additional treatment was provided but the patient's hospitalization period was extended.There was no report of a malfunction of any of the medical devices used during the procedure.There were no reports of further patient or user harm associated with this event.Patient identifier (b)(6) reports the electrosurgical generator used in this event.Patient identifier (b)(6) reports the single use electrosurgical knife used in this event.Patient identifier (b)(6) reports the evis lucera elite gastrointestinal videoscope used in this event.Patient identifier (b)(6) reports the single use electrosurgical hemostatic forceps used in this event.This medwatch report is for patient identifier (b)(6).

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 3 years since the subject device was manufactured.Based on the results of the investigation, it is unknown what device and how the device was involved in the event.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "operation: never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.While the endotherapy accessory extends from the distal end of the endoscope.While the bending section is locked in position.Insertion or withdrawal with excessive force.While the image is electronically zoomed using the function of the video system center.¿the endoscopic image may be distorted while switching between wli observation mode and nbi observation mode.Therefore, do not perform any endoscopic operation or treatment while switching between wli observation mode and nbi observation mode.Injury in the body cavity, bleeding, and/or perforation may result.¿ ¿refer to "2.2 specifications" and "combination equipment" on page 83 for devices that can be used in combination with this product.If a device is selected for use solely based on "maximum insertion diameter" or "effective length," it may not only break or drop out of the device, but may also cause damage to the body cavity, bleeding, or perforation.¿ ¿if the distal end of an endotherapy accessory is not visible in the endoscopic image, do not open the distal end or extend the needle of the endotherapy accessory.This could cause patient injury, bleeding, perforation, and/or equipment damage.¿ ¿do not switch between wli observation mode and nbi observation mode while using an endotherapy accessory.The endoscopic image may be distorted while switching between wli observation mode and nbi observation mode.This could cause patient injury, bleeding, and/or perforation.¿ ¿when using endotherapy accessories, do not use the electronic zoom function of the video system center.It may not be possible to see the position of the accessory in the endoscopic image.This could cause patient injury, bleeding, and/or perforation.¿ ¿securely attach the distal attachment, the single use distal attachment, or the distal hood to the distal end of the endoscope using medical tape.Otherwise, it could fall off while using the endoscope.¿ ¿do not insert endotherapy accessories forcibly or abruptly.The endotherapy accessory may extend from the distal end of the endoscope abruptly, which could cause patient injury, bleeding, and/or perforation.¿ ¿do not withdraw the endotherapy accessory if the tip is open or extended from its sheath; patient injury, bleeding, perforation, and/or endoscope damage may occur.¿ ¿never emit high-frequency current before confirming that the distal end of the high-frequency endotherapy 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 endotherapy 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.¿ ¿to avoid patient injury, burns, bleeding, and/or perforation as well as damage to the endoscope, set the electrosurgical unit to the minimum necessary output level.¿ ¿to avoid patient injury, burns, bleeding, and/or perforation as well as damage to the endoscope, do not activate laser radiation before confirming that the tip of the laser probe appears in the proper position in the endoscopic image.Keep an appropriate distance between the target and the endoscope¿s distal end, and always use the lowest power output possible.¿ this supplemental report includes a correction to g2 to include information that was inadvertently not included on the initial medwatch.Also, information has been added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 16440644
• MDR Text Key: 310232582
• Report Number: 9610595-2023-03267
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H290T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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: FD-411QR WITH SERIAL/LOT UNKNOWN; KD-655Q WITH SERIAL/LOT UNKNOWN; WA90003J WITH SERIAL/LOT B000609
• Patient Outcome(s): Hospitalization
• Patient Sex: Male