MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Defective Component (2292)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, that the oes cystonephrofiberscope instrument port channel was loose.The event occurred during preparation for use, prior to an unknown procedure.It was reported that the issue was discovered during initial setup (out of box failure) when the customer was attempting to attach a stop cock to the cyf-5 scope.There was no report of patient harm or user injury associated with this event.

Event Description

Additional information received from the customer that the event occurred during preparation for use, prior to a cystoscopy procedure.The procedure was completed using similar device with no delay.There was no patient involvement or user injury associated with this event.

Manufacturer Narrative

This report has been submitted to provide additional information from the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned therefore no inspection results are available.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Approximately less than 1 year has passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, since there was no detailed inspection result of the device, it was not possible to judge the factors that led to loosening of the forceps moulds.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15481374
• MDR Text Key: 305746662
• Report Number: 9610773-2022-00433
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2022

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-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/27/2022; 10/27/2022
• Supplement Dates FDA Received: 10/23/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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