MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA HYSTEROVIDEOSCOPE

Model Number	HYF-V
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.The olympus ess found that the facility had a leak tester, recently purchased cleaning brushes and does manual high level disinfection.The ess completed a reprocessing in-service on the olympus hysterovideoscope and demonstrated use of the leak tester and brush with appropriate cleaning brushes and offered to return to observe reprocessing.The ess also provided a cleaning guide wall poster and ensured that a reprocessing manual was on site.Additionally, the facility manager was instructed to acquire appropriate sized high level disinfection bins for manual disinfection the investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
During an onsite in-service demonstration by an olympus endoscopy support specialist (ess), it was noted that the user facility staff was not leaking testing the hysterovideoscope; had not been brushing the channel of the hysterovideoscope; and they did not immerse the light guide or connectors in the high level disinfectant.There were no reports of patient infections or injuries reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d8, of the initial medwatch.The information was inadvertently left out.The endoscope support specialist (ess) was onsite (b)(6) 2023, during the reprocessing in-service with the staff, they covered the guidelines on reprocessing the olympus scopes per the on-track form and reprocessing manual.The staff also performed a return demonstration to show they understood the process.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: ¿ do not coil the insertion tube, universal cord or video cable into a diameter of less than 10 cm.Equipment damage can result.¿ do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end.Visual abnormalities may result.¿ do not twist or bend the bending section with your hands equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿ do not insert the video connector while the electrical contacts are wet.The endoscopic image may not be visible.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Common Device Name: HYSTEROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18256505
• Report Number: 3002808148-2023-13642
• Device Sequence Number: 6582331
• Product Code: HIH
• UDI-Device Identifier: 04953170340185
• UDI-Public: 04953170340185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HYF-V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown