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

Model Number OER-PRO

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

The cause of the reported positive culture cannot be determined as the investigation is ongoing.If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

As part of investigation of the post-market study for duodenoscopes, the manufacturer was informed that the user facility's oer-pro final rinse water tested positive for blastomonas natatoria / blastomonas ursincola.The total number of colony was 10 cfu.The water sample was collected at the end of a standard reprocessing cycle.No endoscope was placed in the oer-pro when the reprocessing cycle was ran for the sampling.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.The user facility reported the oer-pro is functioning properly.There was no allegation of a malfunction on the oer-pro.The last time a preventative maintenance (pm) was performed on the oer-pro was on june 16, 2019.There were no problems noted during the last pm.The user facility noted the minimum effective concentration of the acecide-c is checked daily.The maj-824 filter is changed every six months; last replaced in july 2019.The maj-822 and maj-823 filters are changed monthly; last changed in october 2019.

Manufacturer Narrative

Engineers and a field service representative visited the user facility.The engineers collected a sample of the final rinse water from the automated endoscope reprocessing (aer) machine.The sample tested positive for blastomonas natatoria (1cfu) which was categorized as high concern.Blastomonas natatoria was also identified in the initial sampling.After the resampling, the site replaced the water filter (maj-824) and the disinfected the water supply piping.The field service representative observed the process and reported the following; observed that no deviations were observed.After the replacement the water filter, the olympus engineers collected a sample form final rinse water from the machine again.The sample tested negative.The exact cause of the reported event could not be conclusively determined at this time.

Manufacturer Narrative

This supplemental report is being submitted to provide the summary of the root cause for the post market surveillance with the referenced tjf study.The oem provided the following: olympus conducted resampling of final rinse water taken from the oer-pro (s/n (b)(4)), and same microorganism (1cfu) at the initial sampling was detected during resampling.After resampling, an engineer replaced the water filter and disinfected the water supply piping of the two oers.Olympus sampled final rinse water from the two oers again, and the culturing results of the samples tested negative.Olympus confirmed maintenance record and found that the oers has been maintained following ifu.

• 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: 9151688
• MDR Text Key: 214622590
• Report Number: 8010047-2019-03481
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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