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

Model Number CYF-VHA

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not cleaned, disinfected, or sterilized before coming in for repair.The presence of foreign material adhering to the device was unknown.Pre-cleaning information: there was no delay to the start of pre-cleaning which was done properly.Water was aspirated through the instrument/suction channel.The accessories used for reprocessing showed abnormalities.The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, insufficient bending angle, insertion scratches and wrinkles, dirt that did not come off when the brush inserted, video cable scratches, chipped curved rubber joint, video connector scratches, light guide connector scratches, video connector case scratches, and operation part scratches, switch-box scratches, operation part cover scratches, grip scratches, angle lever scratches.Up/down plate scratches, and up/down angle fixing lever scratches.The faulty parts will be replaced, and the device will be returned to the user facility.The subject device was returned to olympus for device evaluation and investigation confirmed the reported issue during investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation noted that it has been more than one year since the device was manufactured.The investigation did not establish a definitive root cause for the reported event.Investigation could not identify what the foreign material was and since leak failure occurred in the forceps channel, reprocessing could not be completed, resulting in the residue of foreign material.Olympus will continue to monitor field performance for this device.

Event Description

A user facility submitted a repair request to the olympus service center, for a cysto-nephro videoscope, having air leaking from the scope.Upon inspection and testing of the returned device, foreign material was found in the scope suction channel due to insufficient cleaning.It was reported that the scope was used in a procedure with the foreign material attached.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16797268
• MDR Text Key: 313844980
• Report Number: 3002808148-2023-04126
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2023

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: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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