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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the hysterovideoscope bedside precleaning was not being performed.The customer was educated on proper bedside precleaning immediately post-procedure.The customer has plan in place to begin proper bedside precleaning per the instruction for use (ifu).There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.The endoscopy support specialist (ess) performed an on-site visit to the facility and confirmed the event.Based on the observation summary report from an endoscopy support specialist (ess), there were some reprocessing deviations observed during the on-site visit, it was noted that bedside precleaning was not being performed.Training was provide to customer on proper bedside precleaning procedures that to be carried out immediately post-procedure.The ess provided a reprocessing in-service or reprocessing training to the user facility staff.The ess provided the user facility staff reprocessing training materials for their reference.The instruction manual states the reprocessing method associated with the event in "chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures".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: 19651313
• Report Number: 3002808148-2024-05976
• Device Sequence Number: 6616996
• Product Code: HIH
• UDI-Device Identifier: 04953170340185
• UDI-Public: 04953170340185
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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