MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Mechanical Jam (2983)

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

Event Date 09/27/2021

Event Type  malfunction  

Event Description

As reported for this event by the customer, during reprocessing the load process was started with inadvertently closing the drawer without loading the disinfectant bottles in it.The disinfectant had been drained over the weekend.The drawer locks systematically in the loading process and cannot be reopened for loading.This caused the device to be stuck in the loading process.There is no patient involvement.

Manufacturer Narrative

Customer called the technical assistance center (tac), and a tac specialist guided the customer into resolving the issue.An e05 error drain error was induced by lifting the float sensor.The error was cleared, and customer was able to run a drain cycle, instead of the loading cycle.Once the drain cycle was completed, the disinfectant bottles could be loaded into the drawer and the loading process recommenced without issues.The device is not available for evaluation, since the issue was resolved by trouble shooting; as such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

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.Based on the results of the investigation, the disinfectant bottle drawer is unlocked only during the process of replacing the detergent solution.The drawer is locked again when a sensor detects that the cassette bottles are placed in the drawer.It is likely that the sensor temporarily failed at detecting if the bottles were placed in the drawer.The specific root cause of the sensor not detecting if the bottles were placed in the drawer could not be determined at this time.The following information is stated in the instructions for use which may have prevented the user closing the drawer without the bottles in it: "chapteer7, setting up the disinfectant solution: place the disinfectant cassette bottles before closing the disinfectant bottle drawer, when loading the disinfectant solution at the following chapter." olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12673617
• MDR Text Key: 281850122
• Report Number: 8010047-2021-13499
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2018
• 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