MAUDE Adverse Event Report: OLYMPUS AMERICA, INC CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.The olympus representative for the facility reported they were reprocessing cyf-vh urology scopes in the oer.There are no patient incidents reported.The hospital notice sent to patients was precautionary.To date, no patient harm has been reported to olympus personnel.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.(b)(6) - patient 1 - cyf-vh.(b)(6) - patient 2 - cyf-vh.(b)(6) - patient 3 - cyf-vh.This medwatch report is for patient identifier (b)(6).

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16142637
• MDR Text Key: 307162322
• Report Number: 2429304-2023-00002
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• 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: 12/17/2022,01/11/2023

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: CYF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2022
• Event Location: Other
• Date Report to Manufacturer: 12/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other