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

Model Number CYF-5

Device Problem Break (1069)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center confirmed the reported issue.In addition, the device failed the leak test due to damage of the bending cover and damage to the bending section such as adhesive peeling and had hole, bite mark on bending section and restricted forceps passage.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus the rubber tip of the device is falling apart.The event was found in reprocessing and did not involve a patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred due to external force applied to the a-rubber.The following verbiage is identified within the instruction manual: - "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 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: 12526905
• MDR Text Key: 281669264
• Report Number: 8010047-2021-12230
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 09/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1