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

Model Number OER-PRO

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, an olympus field service engineer (fse) visited the user facility to evaluate the device, to provide a preventative maintenance, and to provide a reprocessing training on the use of the automated endoscope reprocessor (aer).On january 16, 2018, the oer-pro was removed from use at the user facility.On january 17, 2018 the fse examined the error log files of the oer-pro at the user facility and assisted the user facility staff in collecting water samples to send to an independent laboratory for microbial testing.The fse found that the last water line disinfection was performed on october 8, 2015.The water line disinfection process is required anytime the internal water filter is replaced or if the device receives any internal service/repair.The instruction manual states, ¿be sure to perform the disinfecting of the water supply to prevent growth of water-borne microorganisms.Failure to perform this operation could result in contamination of the device piping and ineffective reprocessing of the endoscope." in addition, the fse found the drain hose pushed down into the water drain trap, coming in contact with water found inside the trap.The instruction manual states, ¿to prevent discharge failure; always leave the drain hose tip open to the air inside the floor drain (the hose tip should not be immersed in liquid).¿ the fse has addressed this issue with the user facility¿s biomed.The hose was trimmed and has been installed properly.The fse completed a cycle run of the device and no errors were observed.The fse also completed an inspection of the device and the device passed all inspection.On january 23, 2018 a reprocessing in-service training was conducted at the user facility to demonstrate the use of the oer-pro.Olympus was further informed by the user facility that the water samples taken from the oer-pro came back with negative results.

Event Description

Olympus was informed that two patients' were examined by one bronchoscope on two different dates.The first patient who was clinically suspected of (b)(6) was examined on (b)(6) 2018.The procedure was successfully completed.The second patient was then examined with the use of the same bronchoscope (bf-1t160) on (b)(6) 2018 and was likely contaminated from the previous patient/procedure.The user facility reported that the bronchoalveolar (bal) samples collected from both patients tested (b)(6) for mycobacterium (b)(6).The bronchoscope was said to have been reprocessed in an oer-pro.The user facility further reported that ¿as of (b)(6) 2018 the first ¿index¿ patient was (b)(6) for (b)(6).The second patient has shown negative afb smears testing x3 from an induced sputum sample.The facility is awaiting final analysis of this culture.¿ the current conditions of both patients are unknown.Olympus is filing reports to account for the number of suspected devices (bf-1t160 and oer-pro).The 2 of 2 reports.

Manufacturer Narrative

The supplemental report is being submitted to provide the on-site device evaluation findings.Olympus visited the user facility to evaluate the oer-pro automated endoscope reprocessor (aer) machine.Olympus found that there were no functional anomalies related to the reprocessing ability of the oer-pro.The log data on the oer-pro showed that from january 9, 2018 to january 11, 2018 a total of 29 cycles was performed and recorded.The log data also showed that the disinfectant was replaced after 20 cycles or less.In addition, the log data showed that an airway mobile scope (maf-tm) was reprocessed with an endoscope (bf-1t160) which is not compatible.The list of compatible endocsopes/connecting tubes for the oer-pro provides a warning statement in an effort to prevent cross contamination."endoscopes listed in group 1 (bf-1t160) must not be reprocessed in combination with endoscopes listed in group 2 (maf-tm).These combinations may limit the effectiveness of cleaning and disinfection.¿.

Manufacturer Narrative

This supplemental report is being submitted to provide the independent laboratory test results.As part of our investigation, the referenced oer-pro was sent to an off-site laboratory for further testing.The test noted that 6-log reduction was achieved at all test sites and the results indicated effective high-level disinfection of olympus flexible bronchoscopes.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7272402
• MDR Text Key: 100141428
• Report Number: 2951238-2018-00118
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• PMA/PMN Number: PK103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Device Catalogue Number: OER-PRO
• Device Lot Number: N/A
• Other Device ID Number: 04953170258589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BF-1T160, SN# (B)(4) ; BF-1T160, SN# (B)(4)
• Patient Outcome(s): Other