MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CYSTOSCOPE - 2726306F - OLYMPUS CYF -5; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 2726306F-CYF -5

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2023

Event Type  Injury  

Event Description

A cystoscope piece that broke off in a patient.The piece of scope was retrieved but was discarded by the team.The patient returned to operating room for removal.Cystoscope - 2726306f - olympus cyf -5.

• Brand Name: CYSTOSCOPE - 2726306F - OLYMPUS CYF -5
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.
• MDR Report Key: 18425361
• MDR Text Key: 331764515
• Report Number: MW5149688
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2023

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: 2726306F-CYF -5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male