MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Microbial Contamination of Device (2303)

Patient Problem Viral Infection (2248)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.Link to article provided by reporter.Https://www.Wsoctv.Com/news/local/9-investigates-atrium-health-alerts-man-possible-hiv-exposure-year-after-procedure/nqxvrpfpmzepphxv4p2jvqb7jy/?outputtype=amp link to second article provided by reporter.Https://www.Wsoctv.Com/news/local/9-investigates-3-test-positive-viruses-after-potential-exposure-atrium-health-urology-office/rstuksbxdzad3hb2upav46nmsm/ this report has been submitted by the importer under this mdr report number 2429304-2022-00157.

Event Description

An olympus representative reported to olympus, he had seen a news report on tv of a potential exposure of hepatitis b and hiv to patients at a facility where olympus equipment was potentially used.A second olympus representative reported an updated news report which stated three (3) patients tested positive for infectious diseases at the same facility.There was one (1) who tested positive for hepatitis b and two (2) patients for hiv.It was also reported the customer was not changing the chemical nor testing minimum recommended concentration (mrc) or using alcohol with 2 oer-pro machines.It is known that this facility uses olympus devices; however, the relationship between the affected patients and any olympus devices has not been determined.This medical device report (mdr) is being submitted to capture the potential infections that may have been caused by olympus endoscopes reprocessed with either of the 2 oer-pros used at this facility.The following medwatch reports are related: (b)(6), 1st oer-pro, patient 1, hepatitis b; (b)(6), 1st oer-pro, patient 2, hiv; (b)(6), 1st oer-pro, patient 3, hiv; (b)(6), 2nd oer-pro, patient 1, hepatitis b; (b)(6), 2nd oer-pro, patient 2, hiv; (b)(6), 2nd oer-pro, patient 3, hiv.This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a relationship between the subject device and the patient infections could not be identified.Therefore, the root cause could not be determined.However, it is likely that the user did not thoroughly read the instructions for use (ifu) and had insufficient equipment knowledge.The event can be detected/prevented by following the ifu which state: ¿checking the disinfectant solution concentration level: prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life.¿ ¿inspecting and replenishing alcohol: the alcohol used with the equipment must be 70% ethyl alcohol or isopropyl alcohol.Using any other kind of alcohol may result in malfunction of the equipment or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol.¿.This supplemental report includes a correction to e4 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15947665
• MDR Text Key: 305146824
• Report Number: 9610595-2022-05155
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/05/2023
• 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
• Patient Outcome(s): Other