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

Model Number HYF-V

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

An olympus ess visited the customer site to perform an annual refresher training for clinical staff on reprocessing the endoscope.Prior to in-service, the ess requested that the staff perform a walk-through of their current process.The staff recently received access to the channel brush required for the endoscope (bw-400), and the staff had only been using the channel opening and distal of the bw-411 brush, which does not pass through the insertion tube.The staff has access to 3 small bins, for all of reprocessing and manual hld which do not fit the endoscope.They have only been manually cleaning the insertion tube (wipe down) and control body, leaving the remaining portion of the endoscope out of the detergent/disinfectant.The staff had not been adequately measuring detergent per gallons of water and were not sure how many clean water rinses their disinfectant manufacture requires.The olympus ess provided all staff a reprocessing in-service to include pre-cleaning, manual cleaning as well as manual high level disinfection/rinse.The physician assistant was provided information on size required containers to properly submerge and reprocess the endoscope.The physician assistant and staff were instructed that all brushes are single use, and will require to be discarded after each use; therefore an adequate supply of brushes is needed.It was also suggested to measure and mark their basins for reprocessing for the water level to be able to accurately measure detergent for manual cleaning.The physician assistant was provided the reprocessing manual to have available for all staff who will be reprocessing the endoscope, also provided a pdf copy of the reprocessing/disinfection wall chart for the endoscope model as well via email.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the toot causes as to the reason the staff used bw-411 brush only for channel opening and tip and did not pass through and clean the entire insertion tube, the reason the staff had access to three small bins for all reprocessing and manual high level disinfection (hld)s that do not fit in the endoscope, the reason staff only manually cleans the insertion tube (wipe down) and the control unit; the rest of the endoscope is not soaked in the cleaning or disinfection solution, and the reason the staff does not measure enough wash solution per gallon of water and is unsure of the rinse line required by the disinfectant manufacturer could not be determined.The indicated items can be prevented by the following instruction manual: visera hystero videoscope olympus hyf type v-reprocessing manual (chapter 1-7).Olympus will continue to monitor field performance for this device.

Event Description

During an in-service demonstration with an olympus endoscopy support specialist (ess), it was noted that the hysterovideoscope was reprocessed incorrectly.There was no reported patient harm or impact due to this event.

• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Type of Device: 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18225194
• MDR Text Key: 329354597
• Report Number: 3002808148-2023-13413
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170340185
• UDI-Public: 04953170340185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 11/29/2023

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
• Device Operator: Health Professional
• Device Model Number: HYF-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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