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

Model Number CYF-VH

Device Problem Material Twisted/Bent (2981)

Patient Problems Unspecified Kidney or Urinary Problem (4503); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The scope was used on a patient with a stricture.Had a difficult time removing the scope.When the scope was removed the tip was out of alignment.The patient had trauma to the area and needed to go to the or.This is all the detail i was given.Requested for more information.The customer reported the patient had a therapeutic prostate resection for benign prostate hyperplasia/stricture.During the procedure, the surgeon had a difficult time removing the endoscope since the tip was out of alignment.The patient experienced unspecified trauma and needed to go to the operating room for treatment with an olympus resection set.The patient's current health condition is unknown.It is unknown if there was a surgical delay.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The olympus service center evaluated the device and identified the following: distal end is separated from the bending tube insertion tube is leaking m-case is cracked protector on the video connector side is cut restriction at bending tube distal sheath adhesive peeling, blunt scratches once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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 3 years since the subject device was manufactured.Based on the results of the investigation and the inspection of the subject device during evaluation by olympus, it could not be determined if it was difficult to remove the scope due to the stenosis or due to the detachment of the tip from the curved tube.However, it is likely that peeling from the curved pipe at the tip may have occurred due to the same cause as other breakage.However, it could not be determined if the peeling was due to stress, handling, or other factors.This supplemental report includes a correction made to d9 from the initial medwatch.Also, additional information added to h4.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: 15650561
• MDR Text Key: 302184466
• Report Number: 3002808148-2022-03420
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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; Required Intervention