MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the issue was confirmed.The distal end unit was disconnected from the bending tube/the tip was cut from the bending tube.The light guide cover lens was scratched.The bending section cover cement was defective.The connecting tube was peeling off and was scratched.The universal cord was scratched, and the angulation wires and knobs needed to be adjusted.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause could not be identified.It was likely the tip was cut from the bending tube due to handling.The instructions for use (ifu) provides the following guidelines: chapter 3 preparation and inspection: the equipment prepared before using this endoscope and procedures for the inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection: the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If this endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning: using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.This endoscope was not reprocessed before shipment.Before using this endoscope for the first time, reprocess it according to the instructions as described in the endoscope ¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.

Event Description

It was reported by the customer, the cysto-nephro videoscope had a kink in the biopsy channel.It was unknown when the issue occurred but involved a therapeutic procedure.No patient harm reported.During the evaluation of the device, it was noted there was looseness / deformation / scraping / rattling / detachment of the instrument channel port.No patient involvement reported.This report is to capture the reportable malfunction of looseness / deformation / scraping / rattling / detachment of the instrument channel port noted at estimation.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12618470
• MDR Text Key: 276404819
• Report Number: 8010047-2021-13066
• 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: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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: 09/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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