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

Model Number CYF-5

Device Problems Peeled/Delaminated (1454); Material Puncture/Hole (1504)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation, upon inspection the unit failed the leak test the unit was taped and leaking, the distal sheath adhesive is torn, the control body missing the color code.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the rubber on their oes cystonephrofiberscope was damaged and the metal was protruding.The reported event occurred during reprocessing before use.The procedure was completed with a similar device.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation, possible causes for the reported issue may include: device handling, stress, or other issues.A definitive root cause cannot be identified.This issue is covered in the instructions for use: 3.2 preparation and inspection of the endoscope inspection of the endoscope 6.Gently hold the midpoint of the bending section and a point 10 cm from the distal end of the endoscope¿s insertion tube for scratching, cracks, stains or other irregularities.Olympus will continue to monitor the field performance of this device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.

• 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: 14224990
• MDR Text Key: 299310431
• Report Number: 8010047-2022-07146
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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