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

Model Number GIF-H290T

Device Problem Contamination (1120)

Patient Problem Transmissible Spongiform Encephalopathy(TSE) (4556)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.Due to a pinhole on the bending section cover and channel tube, water tightness was lost.The bending angle of the up direction and the play of the up and down knob did not meet specifications due to a worn angle wire.The distal end cover, connecting tube, lock engagement lever, lock engagement lever knob, right/left/up/down knob, switch box, suction cover, suction connector, universal cord, grip, switch 1, suction cylinder, control unit, and switch 4 were scratched.The forceps channel port was shaved, and the paint on the air/water cylinder was peeled.Due to a scratch on the objective lens, flare occurs.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility returned the evis lucera elite gastrointestinal videoscope to olympus for pinhole water leakage as well as insertion curved rubber and insertion forceps channel air leakage.It was then discovered that the device has been associated with a patient suspected to have creutzfeldt-jakob disease (cjd).This patient reportedly underwent an emergency endoscopy in mid (b)(6) 2023 and was currently being tested for cjd.The patient had undergone various unspecified tests, but the infection could not be confirmed at this time.The scope was used on an unknown number of patients and was reprocessed in a reprocessor.No further information was provided at this time.The related complaint with patient identifier (b)(6) reports the unknown number of patients that the scope had been used on.

Manufacturer Narrative

Correction to g2, health professional was inadvertently selected on the initial report.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.Based on the results of the investigation, a root cause could not be determined.According to follow-up with the customer cjd was not confirmed.Despite good faith attempts the user culture results were not shared.The instruction manual reprocessing manual ¿chapter 1 general policy, 1.4 precautions¿ describes the following warning: "[warning] ·prions, which are the pathogenic agents of the creutzfeldt-jakob disease (cjd), cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual.When using the endoscope and accessories on patients with cjd or variant creutzfeldt-jakob disease (vcjd), be sure to use them for such patients only, or immediately dispose of them after use in an appropriate manner to prevent the usage of exposed devices on other patients.For methods to handle cjd, follow the respective guidelines in your country.·the endoscope and accessories may be damaged by published methods for destroying or inactivating prions.For information on the durability of olympus equipment against a particular reprocessing method, contact olympus.In general, olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual.If you choose to use a reprocessing method not recommended in this manual, the local institution and / or physicians must assume responsibility for its safety and efficacy.Make sure to carefully inspect each piece of endoscopic equipment for irregularities (damage) prior to each patient procedure.Do not use the equipment if any irregularity is observed." olympus will continue to monitor field performance for this device.

Event Description

Olympus received further information that the patient was suspected to have creutzfeldt-jakob disease (cjd) on july 10 based on mri findings.A cerebrospinal fluid (csf) test and prior gene analysis also showed suspicion of cjd.An electroencephalography (eeg) showed no abnormalities.There were no specific patient symptoms.The scope had been used on june 12 in a procedure to check for upper gastrointestinal bleeding in the stomach.There was "no doubt" that it was alleged that the patient contracted the suspected cjd from the scope.A follow up was done and the patient was transferred to a hospital.No fatality was reported.The customer further reported that the scope was used on 17 patients after it was used on the patient suspected with cjd.It was reportedly used in 10 treatment procedures (1 patient for percutaneous endoscopic gastrostomy (peg), 3 for gastric ulcer hemostasis, 2 for esophageal varices treatment, 1 for duodenal tumor resection for gastric cancer, 3 for endoscopic submucosal dissection (esd) for gastric cancer) as well as in 7 observation procedures (3 patients for chronic gastritis, 1 for gastric cancer, 1 for gastric ulcer, 1 for duodenal ulcer, and 1 for esophageal varices).None of these 17 patients developed any infections or cjd.The scope was not cultured.The 17 patients on which the scope was used on after it was used on the patient with suspected cjd are reported on patient identifiers (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information as reflected in b5.Please see updates to b2, b3, b5, h6, and h10.The customer provided the reprocessing steps for the endoscope.Air and water were suctioned at the bedside, brushing was performed at the sink, and then cleaning and disinfection with the oer.The scope was reprocessed in 3 oers.

• 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: 17493667
• MDR Text Key: 320810180
• Report Number: 9610595-2023-11423
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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
• Patient Outcome(s): Other; Hospitalization