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

Model Number OER-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility found three patients were infected with unspecified microbes on (b)(6) 2020.The three patients underwent endoscopic procedures using cyf-vha on (b)(6) 2020.The patients' outcome is reportedly as follows.First patient: fever.Second patient: fever and hospitalization.Third patient: unknown.The cyf-vha had been reprocessed with an olympus automated endoscope reprocessor model oer-s using peracetic acid.The concentration of disinfectant of the oer-s was effective.The user wipes the cyf-vha with a sterile cloth after automated reprocessing cycle and stores the device in the basin of the oer-s until next procedure.Olympus is submitting 3 medwatch reports for the oer-s.This is the 3rd of the 3 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.A potential cause of the event is as follows.The customer had stored the endoscope by placing it in the reprocessing basin of the olympus endoscope reprocessing machine, oer-s.The reprocessing basin has high humidity and microorganisms are easy to grow in the environment.The endoscope was likely to be contaminated when being stored in the basin.In addition, reportedly, the user didn¿t check the concentration of the disinfectant solution or change disinfectant solution in accordance with the instruction manual.

• 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 Key: 10193949
• MDR Text Key: 201078013
• Report Number: 8010047-2020-03633
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other