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

Model Number OER-AW

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device has been returned to the service department of olympus (b)(6) co., ltd.(oth) for inspection.The inspection confirmed followings; the gas filter and air filter were worn and had expired.There was a dirty stain on the lid.There was no water filter.There was a dirty strain on the sink and other parts.An opa(ortho-phthalaldehyde) test of the disinfectant in the device was done and failed.The disinfectant was not active.Atp(adenosine tri-phosphate) tests were conducted at 10 locations such as device connectors and sinks, but all passed.Bacterial volume was less than 200 rlu at all test locations.Oth said the parts need to be replaced and the device cleaned.The following information was obtained from the customer.In the culture test reported in b5, the customer found a little bit volume of ¿microbacterium cosmeticum¿ in the pcr test.The quantity value is not shown.The doctor does not take any action or additional treatment for the patient.Training for this customer on this device took place on (b)(6) 2020.This participant was one of the main members of the reprocessing process.Upon being notified of the infection, oth retrained this customer about reprocess methods and caution on (b)(6) 2021.After the training, a test was conducted to confirm the customer's knowledge.Oth will train the customer again before oth returned the device to the customer.Oth speculated that the device's malfunction was not the cause of the infection.Oth said user handling could be the cause of the infection, as the disinfectant has expired and the cleaning tube is brownish.By removing the water filter, the water may not be clean and the cleaning tab and parts may become brown and wear quickly.The exact cause of the reported event has not yet been identified by legal manufacturer olympus medical systems corp.(omsc) for this device.If significant additional information is received, this report will be supplemented.

Event Description

Olympus received reports of eight patient infections associated with this device.The customer found the first patient infection on (b)(6) 2021.The customer conducted culture tests on all their devices and areas to determine the cause of the infection.As a result, the auxiliary water / elevator wire channel connector of this device tested positive.After that, the customer detected that additional 7 patients were infected.Olympus became ware of the first infection case on (b)(6) 2021 and the other cases on (b)(6) 2021.This mdr reports the fourth infected person.This event is related to mfr report # 8010047-2021-04010.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.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.Based on the investigation results, olympus medical systems corp.(omsc) assumed that the patient infection was caused by followings: the endoscope was reprocessed with this device, which was positive in culture.Then, the endoscope was used on the patient.The patient indirectly contacted the auxiliary water/elevator wire channel of this device.Omsc also assumed that the event that the culture result of this device was positive was caused by followings; the endoscope was cleaned and disinfected when the disinfectant concentration was not active.The customer continued to use this device without cleaning it.The customer continued to use this device without using a water filter.The instruction manual provides preventive measures against the reported misuse.In addition, the device instruction manual also calls attentions to disinfectant concentration, device cleaning, and the need for water filters.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This late mdr is being submitted as a result of a complaint retrospective review.Based on the results of the investigation, it was not possible to determine the relationship between the events and the device.A definitive root cause cannot be identified.The customer detected microbacterium cosmeticum.It was confirmed that the disinfectant concentration was not the effective concentration.The water filter was not used.This information is addressed in the instructions for use (ifu): "chapter 8 troubleshooting and repair 3.10 checking the disinfectant solution concentration level prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life.Chapter 5 end-of-day checks to ensure safe, reliable operation, inspect and clean all parts of the device regularly.Chapter 7 routine maintenance to ensure safe operation of the device, it should be cleaned and inspected regularly.Parts and consumables should be added or replaced as required." olympus will continue to monitor the field performance of 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: 11587464
• MDR Text Key: 258024241
• Report Number: 8010047-2021-04335
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 03/18/2022
• Supplement Dates FDA Received: 05/13/2021; 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR