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 10/30/2023

Event Type  malfunction  

Event Description

Olympus was informed that during an onsite visit, the user facility staff was not leak testing the endoscopes prior to reprocessing.Staff currently do not have access to the channel brush required for this endoscope (bw-400), staff have only been using the channel opening and distal part of the bw-411 brush, which does not pass through the insertion tube.Staff have access to 3 small bins, for all of reprocessing and manual high level disinfection (hld) which do not fit the endoscope, they have only been manually cleaning the insertion tube by wiping down, leaving the remaining portion of the endoscope out of the detergent disinfectant.Staff have not and did not know that their manufacturer of the disinfectant requires 3 water rinses, staff have only been rinsing the endoscope 1 time after manual hld.No patient infections or injuries reported.

Manufacturer Narrative

No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) was dispatched on-site to assess the reprocessing practices at the user facility.Based on the observation summary report from the endoscopy support specialist (ess), there were some reprocessing deviations observed during the on-site visit, and they are as follows: the user facility staff was not leak testing the endoscopes prior to reprocessing.Staff currently do not have access to the correct channel brush required for this endoscope (bw-400), staff have only been using the channel opening and distal part of the bw-411 brush, which does not pass through the insertion tube.Staff have access to 3 small bins, for all of reprocessing and manual high level disinfection (hld) which do not fit the endoscope, they have only been manually cleaning the insertion tube by wiping down, leaving the remaining portion of the endoscope out of the detergent disinfectant.Staff have not and did not know that their manufacturer of the disinfectant requires 3 water rinses, staff have only been rinsing the endoscope 1 time after manual hld.Ess provided information on size requirements for containers to properly submerge and reprocess the endoscope to the facility and complainant.Ess located the leak tester for the facility, and demonstrated how to use the olympus hand held leak tester.Suggested for lead nurse to contact olympus customer service to order the required brush bw-400 to properly brush the endoscope when manual reprocessing.Provided the reprocessing manual to lead nurse to have available for all staff who will be reprocessing the endoscope, also provided a copy of the reprocessing and disinfection wall chart for the endoscope model via email.The ess provided a reprocessing in-service training to the user facility staff.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation ·phenomenon (1) to (5) were estimated and confirmed as the indicated phenomena by the facility.·phenomenon (1) to (5) were investigated because they are pae events.Conclusion of phenomenon (1) to (5): the root cause could not be identified.Discussion of phenomenon (1): since the current device was not returned to the shirakawa plant and the detailed condition of it could not be confirmed, the information obtained from the investigation results did not allow us to identify the root cause or identify the cause of the occurrence of [staff did not leak test the endoscope prior to re-processing].Discussion of phenomenon (2): since the current device was not returned to the shirakawa plant and the detailed condition of it could not be confirmed, the information obtained from the investigation results did not allow us to determine the root cause or identify the cause of the occurrence of [staff did not access the channel brush (bw-400) required for the endoscope].Discussion of phenomenon (3): since the current device was not returned to the shirakawa plant and the detailed condition of it could not be confirmed, the information obtained from the investigation results did not allow us to determine the root cause or identify the cause of the occurrence of [staff uses only the channel opening and the tip of the bw-411 brush, which does not pass through the insertion tube].Discussion of phenomenon (4): since the current device was not returned to the shirakawa plant and the detailed condition of it could not be confirmed, the information obtained from the investigation results could not be used to identify the root cause of the [staff accesses three small bins for all re-processing and manual hlds that do not fit the endoscope and manually cleans only the insertion tube (wipe-down) and control unit without soaking the rest of the endoscope in cleaning or disinfecting solution] or the cause of the occurrence.Discussion of phenomenon (5): since the current device was not returned to the shirakawa factory and the detailed condition of it could not be confirmed, the information obtained from the investigation results did not allow us to identify the root cause or cause of the occurrence of [staff did not know that three rinses were required for manufacturing the disinfection solution and only one rinse of the endoscope after the manual hld].User misuse regarding re-processing was investigated, and it is determined that the indicated items can be prevented by the following instruction manuals.Visera hystero videoscope; olympus hyf type v; reprocessing manual; chapter 1~7.Olympus will continue to monitor field performance for this device.

• 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: 18194305
• MDR Text Key: 328825044
• Report Number: 3002808148-2023-13263
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2023

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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