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

Model Number CYF-VA2

Device Problems Corroded (1131); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

Customer reported with an issue of "there are black dots on the image".The issue found at preparation for use.The device was replaced and the intended diagnostic procedure was completed using a similar device.No patient harm , no user injury reported due to the event.Device evaluation found angulation failure, found to be due to corrosion.This report is being submitted for the malfunction angulation failure due to corrosion found on device evaluation.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection, service repair found forceps channel port corroded.Connecting tube dented.Waterproof failure (leakage) due to the pinhole at connecting tube.Connecting tube corrugated.The insulation resistance value is out of standards due to the corroded connecting tube.There is corrosion from the control unit due to the leakage.Universal cord dented.Video connector has scratches.Grip unit is dirty.Additionally, evaluation found an angulation failure due to the corrosion from angulation device.Angulation in the up direction is out of standards due to the worn angle-wire.Switches # 1 , 3 and 4 found not working due to corrosion.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to leak occurred at the control section during user handling and corroded the inside of the device, causing angulation failure.The event can be detected by following the instructions for use (ifu) which state: inspection of the endoscope: inspect the objective lens and light guide lens at the distal end of the endoscope¿s insertion tube for scratching, cracks, stains, gaps around the lens or other irregularities.Inspection of the forceps elevator mechanism.¿perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.¿ the event can be prevented by following the instructions for use (ifu) which state: "do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ ¿do not insert or withdraw an endo-therapy accessory by force when the forceps elevator is raised to its maximum height.The instrument channel, the elevator wire, and/or the endo-therapy accessory may be damaged and patient injury, bleeding and/or perforation can result.If the endo-therapy accessory cannot be inserted or withdrawn, move the elevator control lever in the opposite direction of ¿u¿ to lower the forceps elevator and insert or withdraw the endo-therapy accessory.¿ olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 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: 15602174
• MDR Text Key: 307079042
• Report Number: 3002808148-2022-03154
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

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: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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