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

Model Number CYF-5

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the user report.The bending section sheath broke off and moisture invaded the scope.The moisture invasion caused a stain on the image.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the cystonephrofiberscope had exposed metal where the rubber was peeling off of the bending section.Per the customer, this was found during reprocessing.There was no patient involvement or impact to patient care reported for this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the rubber a was damaged due to an external force applied to the curved part, leading to the exposure of the metal part.This issue is addressed in the instructions for use (ifu): "important information please read before use warnings and cautions follow the warnings and cautions given below when handling this instrument.This information is to be supplemented by the warnings and cautions given in each chapter.¿ never perform angulation control, suction control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image.Patient injury,bleeding and/or perforation can result.¿ never insert or withdraw the endoscope¿s insertion tube while the up/down angulation is locked.Patient injury and/or equipment damage can result." 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
• MDR Report Key: 12353930
• MDR Text Key: 267676103
• Report Number: 8010047-2021-10615
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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: 07/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1