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

Model Number CYF-VH

Device Problems Peeled/Delaminated (1454); Failure to Clean Adequately (4048)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the tip was loose.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found; the adhesive around the objective lens had foreign objects.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned and evaluated and confirmed as the plastic distal end cover was loose.Evaluation found that there was also corrosion in the adhesive around the objective lens.Additional findings include; forceps channel port had corrosion, switch box had a scratch and due to the adhesive peeling of the distal end, distal end was not secured.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 observed foreign material in the objective lens adhesive could not be identified and a definitive root cause of the issue could not be determined, as there was no deformation that might result in the retention of foreign material and the facility device reprocessing appeared to have been implemented in accordance with the ifu, however, the issue was likely the result of insufficient device cleaning/reprocessing.The issue may be detected/prevented by following the instructions for use below: cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual.Reprocessing survey info: - was the device reprocessed at the customer site before the device sent in the repair center? --> yes.- any malfunction of reprocessing accessories.--> no.- delay of pre cleaning --> no.- delay of manual cleaning (if delayed, pre soaking is required) --> no.- wipe the surface during pre cleaning --> yes.- wiping / brushing the surface during manual cleaning" --> yes.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18370543
• MDR Text Key: 331369898
• Report Number: 3002808148-2023-14594
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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