MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE; FLEXIBLE VIDEO COLONOSCOPE, REUSABLE

Model Number PCF-H190L

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

During a repair reduction observation for the device, the olympus endoscopy support specialist (ess) observed that some of the staff did not complete all the proper steps for the pre-cleaning at the bedside.The leak test was also not performed properly.General care and handling was satisfactory over all.Ess provided an in-service training and recommended additional refresher training if necessary.There is no reported harm to any patient.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The device was repaired in march and may of 2021.This event is not a malfunction of the device but an observation of the pre-cleaning of the device performed by some of the staff at the facility.The root cause of the event cannot be specified conclusively.However, it is inferred that the user¿s understanding differed from olympus recommendation in device handling and reprocessing steps.The instructions for use (ifu) includes the following statements: ifu (reprocessing manual) warns the user against insufficient reprocessing as below: 1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.Reprocessing steps and way are detailed in 5.3 precleaning the endoscope and accessories and 5.4 leakage testing of the endoscope.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO COLONOSCOPE, REUSABLE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15065751
• MDR Text Key: 304803095
• Report Number: 9610595-2022-00122
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305191
• UDI-Public: 04953170305191
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• 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