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 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) went on site to evaluate the issue of the device.Upon inspection, fse noted that the lock system was active in lock position.The bottle sensors may have been touched inadvertently while cleaning of the bottle tray was being performed causing the lock system to be active in lock position.Fse manually pulled back the lock system, installed the new cassette bottle, and started the lcg disinfectant loading process.Lcg loading process was completed with no error.Equipment was repaired and verified according to original equipment manufacturer instructions.Software attributes have been verified and confirmed.The covers of the oer-pro were not removed so an electrical safety check was not required.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, during the endoscopy technician was unable to load the disinfectant back in the bottle tray after cleaning the bottle tray upon removing the used cassette bottle.There is no patient involvement.

Manufacturer Narrative

There is more information on the device evaluation and information for the initial reporter.This supplemental report is being submitted to provide this information.The device history record review confirmed that device conformed to specifications at the time of shipping.It is likely that the user touched a sensor to detect that acecide bottles are placed when cleaning the disinfectant bottle tray.The device may have recognized the accidental touch to mean that the bottles were inserted and therefore activated the lock system.We presume that the sensor malfunctioned, which temporarily caused the sensor to incorrectly react.

• 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: 12782993
• MDR Text Key: 282195645
• Report Number: 8010047-2021-14343
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2010
• 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