MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CYSTOFIBERSCOPE; CYSTONEPHROFIBERSCOPE

Model Number CYF-4

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/24/2023

Event Type  Injury  

Event Description

It was reported, a piece of the scope broke off inside the patient during a fulguration procedure on (b)(6) 2023.The patient came back for a cystoscopy on (b)(6) 2024 and the part of the scope that fell inside the patient on (b)(6) 2023 was discovered at this time and was successfully removed.Additional procedural details were requested but not provided.

• Brand Name: OES CYSTOFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 18990121
• MDR Text Key: 338772427
• Report Number: 2429304-2024-00211
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024,03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention