MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHA

Device Problem Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus malfunctions with three (3) scopes and the malfunctions may have caused patient bleeding during the procedure.The distal tip is dislocated and the image is out of alignment by approximately 90 degrees.A request for additional information is in progress.This event includes 4 reports: (b)(6); patient 1, cyf-vha, (b)(4).(b)(6); patient 2, cyf-vha, (b)(4).(b)(6); patient 3, cyf-vha, (b)(4).(b)(6); patient 4, cyf-vha, (b)(4).This report is 3 of 4.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s complaint was confirmed.The distal tip was dislocated, and the image was out of alignment by approximately 90 degrees.In addition, the following non-reportable malfunctions were also observed: insertion tube bending section ¿ detached; insertion tube condition ¿ delamination; up/down angle ¿ not to specification.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, there were scratches observed on the detached part of the bending section.Thus, the bending section likely detached due to external forces.However, the root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s re-investigation.Based on the results of the re-investigation, since the tip connecting part corresponded to the thin-walled resin part of the device, it was rotated off from the curvature by applying external force.As a result, the image may have been shifted with respect to the 90 degrees curvature direction, likely causing the bleeding.However, the root cause of the reported event could not be identified.Also, correction made to h6 code (investigation findings).Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15679581
• MDR Text Key: 302482367
• Report Number: 3002808148-2022-03588
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 10/28/2022; 12/21/2022
• Supplement Dates FDA Received: 11/22/2022; 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• 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
• Patient Outcome(s): Other