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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR
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OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-PRO
Device Problem Device Handling Problem (3265)
Patient Problems Dyspnea (1816); Discomfort (2330); Chemical Exposure (2570)
Event Date 08/11/2021
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.The olympus field service engineer (fse) was dispatched to the user facility to evaluate the issues.Troubleshooting was performed based on the error logs and actual cycles led the fse to believe there was no current or previous leak in the device.The device performed well with no problems or complications once the sensor covers were replaced.Upon analyzing the logs, the fse determined the errors experienced were associated with the damaged sensor covers.Fse also found that the sensor covers were damaged before the e02 occurred and was most likely the cause of the e02 error.The sensor covers were damaged further after the staff member reacted abruptly to the fumes, resulting in the additional errors experienced after that point.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been reported by importer on mdr report number 2951238 - 2021 - 00392.
 
Event Description
The customer (he) reported to olympus, while running the reprocessor, there was an e02 error during a cycle.The error appeared during the disinfectant phase and was canceled by hitting the stop button twice inadvertently.The technician (she) opened the lid before executing the "rinse" function and was overwhelmed by the fumes from the solvent since the tub was filled with acecide.She required medical attention and was being seen by the doctor.The outcome of the technician is pending.The e02 error was resolved by cleaning the lint out and the scopes were run through the reprocessor without further issues.An attempt to retrieve additional information is in progress.In addition, fluid was observed to be on the floor in front of the unit with no visible signs of moisture on the outside of the machine.There was no fluid observed inside the machine or leaking from anywhere.The customer suspected the fluid was possibly from the scope connector when pulling them out of the unit to re-scan after resolving the e02 error.However, the fluid level sensors were also noted to be cracked in half.The customer called back the same day and reported an e41 power supply error.Troubleshooting was performed and the power cord was found to be a little loose.The error was cleared and the scope was rescanned and the cycle started again.The customer called back a third time to report an e07 fluid level sensor malfunction.The cover was found to be broken.The customer was unsure if the fluid on the floor was due to leaking.The customer was advised not to operate the device without the tub fluid level sensor covers intact.He was also advised to clean the tub fluid level sensors with 70% isopropyl alcohol.The customer called back the next day to report an e04 error message.An olympus field service engineer was dispatched to the facility to repair the device.Equipment repaired, tested and verified to oem specifications.The fse also found no leaks and or indications of leaks during the inspection of the unit which included review of logs and visual inspections.This is for the reportable event regarding the technician being overwhelmed by fumes from the solvent which required medical attention.
 
Manufacturer Narrative
This supplement is being submitted to provide additional information received from the customer.Patient is facility health care professional, surgical support assistant.The investigation is in progress.A supplemental report will be submitted when completed.
 
Event Description
Additional information was received from the customer as follows: the technician is scheduled for to see a pulmonologist.She reports she gets short of breath when taking long walks and has discomfort in her diaphragm that continues.
 
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, it is likely that error e02 occurred during reprocessing by incorrect detection resulting from malfunction of the tub fluid level sensor and the electrode cover.The user health was impacted by breathing fumes from acecide which remained in the reprocessing basin when the lid was opened.Per the legal manufacturer, the other error codes referenced in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.This issue (e02 error) is addressed in the instructions for use (ifu): "chapter 5 end-of-day checks: if any irregularity is observed, do not use the device and contact olympus.If the device is used when an irregularity is observed, the device may malfunction.Water leakage, electric shock, burns, and/or fire may also result." "6.8 rinsing: if cleaning fluid or disinfectant solution remains in the reprocessing basin or in the endoscopes after an irregularity occurs or the process is stopped midway, perform the rinsing process after the air purge process." "chapter 8 troubleshooting and repair: in the event, in case the process stops and disinfectant solution remains in the reprocessing basin due to a power failure or malfunction, do not open the reprocessing basin lid.Otherwise, disinfectant vapor could cause adverse physical effects.When power is restored, drain the reprocessing basin." olympus will continue to monitor the field performance of this device.
 
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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
MDR Report Key12443567
MDR Text Key270499495
Report Number8010047-2021-11454
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
PMA/PMN Number
K103264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberOER-PRO
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age48 YR
Patient Weight72
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