MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The subject oer-3 was not returned to olympus medical systems corp.(omsc).The user will not return the subject oer-3.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 reported that pseudomonas aeruginosa was detected from the stool of two patients.This pseudomonas aeruginosa is not resistant bacteria.No symptoms of infection on the patients had been shown and there was no report of additional treatment to the patients.The user conducted a culture test for all endoscopes and automated endoscope reprocessors in the facility.As a result, two unspecified endoscopes and one oer-3 were test-positive.The water accumulated in the reprocessing basin of the oer-3 was used as the culture sample of the culture test of the oer-3.The type and number of bacteria were unknown.There is no information that a device is specified, which was used for the patients whom pseudomonas aeruginosa was detected from.The local service engineer checked the subject oer-3 and reported that there was no abnormality.This report is the second of the two reports of pseudomonas aeruginosa detection.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-02443.Olympus medical systems corp.(omsc) could not investigate the subject oer-3, because the subject oer-3 is not returned to omsc.Omsc checked the device history record of the subject oer-3, there was no irregularity found.Considering the information provided from the user, it was unclear whether the reported infection was caused by the subject device or already existing before the procedure.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: OER-3 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8171810
• MDR Text Key: 130620237
• Report Number: 8010047-2018-02443
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/25/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other