MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS PLEURA VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-240

Device Problems Break (1069); Microbial Contamination of Device (2303)

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

Event Date 08/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation of a broken bending section cover was confirmed.The bending section cover was leaking.Olympus was unable to microbiologically test the unit.Therefore, the issue of the device testing positive for micoorganisms could not be confirmed.The hospital indicated that they then followed the manual instructions to sterilize the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, improper disinfectant was used on the evis pleura videoscope causing the device to test positive for microorganisms.Rubber on the scope was also noted to be damaged.The event occurred during reprocessing.There was no delay in the procedure and the procedure was completed with a similar device.The name of the intended procedure was unknown.There were no reports of patient harm associated with this event.

Manufacturer Narrative

(b)(4).Break and clarification of event on initial medwatch report.This mdr was being submitted to capture the customer¿s allegation of a positive culture.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, additional information based additional information provided by the user facility and applicable corrections.The customer uses a wanjin complex chlorine disinfectant with a xinhua washing machine for endoscope reprocessing.The customer reportedly checks the minimum effective concentration every day.During manually cleaning, the customer uses reusable brushes.Since the last olympus endoscopy reprocessing servicing, the user facility has experienced changes in reprocessing personnel, however, all reprocessing personnel trained on how to properly reprocess an endoscope.The scope is stored in sealed aseptic storage.No microorganism was detected, which was caused by sterilization without the ethylene oxide (eto) cap during evaluation.The endoscope was newly installed equipment, which had been used previously.The first sterilization test failed and no retest after sterilization occurred.To date, the customer never sent in the culture report and further information provided has suggested that the customer did not find any microorganisms on the scope.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 definitive root cause could not be identified.The relationship between the device and positive culture results could not be determined.The instructions for use (ifu) addresses this issue.Ifu warns on inappropriate reprocessing as follows: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS PLEURA VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• 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: 15451199
• MDR Text Key: 303556562
• Report Number: 9610595-2022-01954
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013617
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2021
• 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