MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number CF-HQ190L

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Bowel Perforation (2668)

Event Date 10/31/2022

Event Type  Injury  

Event Description

The customer reported to olympus that the patient suffered a perforated bowel during a diagnostic gastroscopy and colonoscopy using the evis exera iii colonovideoscope.The customer also mentioned an "issue with the air water working case." the surgeon was not sure how the perforation occurred; but there were reportedly no procedural difficulties noted.Sedation was extended by 2 hours.The patient subsequently had a cardiac arrest due to tension pneumoperitoneum, requiring a laparotomy and ileo-colic resection as well as admission to the intensive care unit.The patient stayed in the hospital for 11 days.The patient was currently doing fine.The device was inspected prior to use.There were no other devices directly involved that could have caused or contributed to the adverse event.

Manufacturer Narrative

The suspect device has not been returned to olympus at this time.Additional information has been requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

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 8 years since the subject device was manufactured.Based on the results of the investigation, a relationship between the reported bowel perforation and the subject device could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿warning for perforation operation manual: important information ¿ please read before use never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope¿s insertion section, or use endotherapy accessories without viewing the endoscopic image or while the endoscopic image is frozen.Patient injury, bleeding, and/or perforation may result.Regardless of the flexibility of the endoscope¿s insertion tube, never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result.If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy.Forcible insertion can result in patient injury, bleeding, and/or perforation.¿ this supplemental report includes information added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 16729108
• MDR Text Key: 313191307
• Report Number: 9610595-2023-06054
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: CLV-190/755060.; CV¿190/7509800.; OEV-261H/7001621.; OFP-2/21 013280.; SCOPE BUTTONS 1032/UNKNOWN LOT NUMBER.; UCR TUBING DES5013/UNKNOWN LOT NUMBER.; UCR/7G23022.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization