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

Model Number OER-PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

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).

• 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
• MDR Report Key: 15947791
• MDR Text Key: 305145037
• Report Number: 2429304-2022-00159
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2022,12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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?: Yes
• Distributor Facility Aware Date: 11/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other