MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Esophagus (2399)

Event Date 08/10/2023

Event Type  Injury  

Event Description

The customer reported to olympus the evis exera iii xenon light source was used during a therapeutic endoscopic ultrasound and endoscopic retrograde cholangiopancreatography (for an unspecified indication) in conjunction with another insufflator when a perforation was noted in the patient¿s esophagus.The user was unaware both devices introduced air into the patient¿s system.As a result, the patient was hospitalized for a few days for monitoring and reported in good condition.No additional surgical or medical interventions were required.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.This event has been reported by the importer on medical device report 2429304-2023-00296.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that insufflation from both a light source and a pneumoperitoneum device resulted in overpressure in the esophagus, leading to the perforation.However, the root cause could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿5.9 air/water feeding: over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation.¿ this supplemental report includes additional information received regarding the event.B5 updated accordingly.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The procedure was completed as intended.Although the subject device (clv-190) was inspected prior to use, it is unknown whether the air was activated intentionally.After being hospitalized for monitoring, the patient was discharged from the hospital.Furthermore, it is unknown whether endoscopic clipping was performed to treat the perforation, as well as if any additional treatments were provided to the patient during the hospitalization.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17777026
• MDR Text Key: 323766881
• Report Number: 3002808148-2023-10056
• Device Sequence Number: 1
• Product Code: NWB
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NON-OLYMPUS INSUFFLATOR
• Patient Outcome(s): Hospitalization