MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, and the exact cause of the reported event could not be conclusively determined.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.An unreprocessed endoscope is being immersed in the reprocessing basin of the subject device during a leak test of the endoscope.After the leak test, the endoscope will be reprocessed.The user collected the culture sample from the water accumulated in the reprocessing basin of the subject device during the leak test of the endoscope.Therefore there was the possibility that this phenomenon was attributed to contamination from the unreprocessed endoscope due to the inappropriate collection of the culture sample by the user.Also, the user reported that no microbes were detected from the reprocessed endoscope.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the oer-4.The culture sample was collected from the water accumulated in the reprocessing basin of the subject device during the leak test of the endoscope.[first time; (b)(6) 2019] the reprocessing basin : bacillus (1000/ml); [second time; (b)(6) 2019] the reprocessing basin : pseudomonas spp.(30/ml).The device had been reprocessed using peracetic acid.There was no report of infection associated with this report.

• Brand Name: OER-4 100V
• 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: 9514645
• MDR Text Key: 219778863
• Report Number: 8010047-2019-04589
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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