MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The user facility did not provide a specific serial number for the device in question; therefore, it is unknown whether the subject device has been returned to olympus for service or not.Olympus contacted the user facility multiple times to obtain additional information regarding the reported event but to no avail.As part of our investigation into this report, olympus offered an on-site visit by an olympus endoscopy support specialist (ess) but the user facility declined the offer.No conclusion can be drawn at this time due to insufficient information provided by the user facility.This report will be supplemented when new information becomes available.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The customer reported that two patients may have developed a urinary tract infection (uti) from the device and requested a copy of the reprocessing instructions for the subject device to ensure that they are reprocessing the scopes correctly.No further information provided.1 of 2 reports, this is related to patient identifier# (b)(4).

Manufacturer Narrative

This report is being supplemented based on additional information provided by the legal manufacturer¿s investigation.To date, the legal manufacturer cannot conclusively determine the cause of the user¿s report, as the user facility has not returned the device for evaluation yet and provided insufficient information regarding the report and device.The legal manufacturer is concerned the way the customer is performing the reprocessing of the device, because the customer has requested the reprocessing manual.According to the legal manufacturer, there had been no similar incidents using the equipment at the user facility and believed that there is no problem with the device in question.Insufficient reprocessing of the device cannot be ruled out as a contributory factor to the reported events.Chapter 7 of the reprocessing manual warns users, ¿all channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.¿.

Manufacturer Narrative

This report is being supplemented to provide h6 codes.

Manufacturer Narrative

This mdr is being submitted as a result of a complaint retrospective review.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Three attempts were performed to obtain additional information but were not successful.It has been confirmed that no similar events have occurred using the device at the same facility up to the present time.If additional information is obtained at a later date, a supplemental report will be submitted olympus will continue to monitor the field performance of this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 11036184
• MDR Text Key: 222318714
• Report Number: 8010047-2020-10654
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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